MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD HEMI HEAD 46MM; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL

Catalog Number	74122546
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Codes	Infiltration into Tissue (1931); Pain (1994); Metal Related Pathology (4530)
Date of Event	05/05/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after a primary r3-tha construct had been implanted on the patient's right hip on (b)(6) 2010, the patient experienced pain and elevated cobalt levels in blood.A revision surgery was conducted on (b)(6) 2022 to address both symptoms.During this procedure, the modular head, the chrome-cobalt liner and the acetabular cup were explanted and replaced with a competitor¿s acetabular system and a smith and nephew femoral metallic head.As part of the intraoperative findings, no signs of metallosis were seen as well as no significant soft tissue destruction of the musculature was noted upon entering the capsule.The modular head was removed and noted to have a small amount of trunnionosis without damage to the stem.Although a preoperative bone scan suggested that the acetabular component was loose, intraoperatively it was denoted that this component showed good bony ingrowth.The patient was awoken form anesthesia and transferred to the recovery room in stable condition.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Additional Manufacturer Narrative
It was reported that a right hip revision surgery was performed on a bilateral patient due to pain and elevated cobalt levels in blood.Intraoperatively, a small amount of trunnionosis without damage to the stem was seen with no signs of metallosis.As of today, the implanted devices, all of which were used in treatment have not been returned for evaluation.A review of the historical complaints data for the hemi head and modular sleeve was performed using batch numbers, part numbers and the reported failure modes to evaluate patterns of repeated failures or defects.Similar complaints have been identified for devices concerned, however, as the devices are no longer sold, no action is to be taken.In the absence of the actual devices, the production records were reviewed for the devices reportedly involved in this incident.All released devices involved met manufacturing specifications upon release for distribution.The review of the products ifu found adequate warnings and precautions in relation to the alleged failure modes.A risk management review was performed.The alleged failure modes and associated risks have been anticipated within the risk file and the anticipated risk level is still adequate.No further actions are required at this time.A review of historic escalation actions related to the products and similar complaint events was performed.Following the review, prior applicable escalation actions were identified and confirmed to reduce associated risks as far as possible.No further escalation actions are required.The available medical documents were reviewed.The intraoperative reported noted, no soft tissue metallosis, bony ingrowth to cup, and mild trunnionosis.The clinical root cause of the reported pain, elevated metal ions, and trunnionosis cannot be confirmed, it cannot be concluded the reported clinical reactions were associated with a malperformance of the implant or implant failure.Based on the available information we can confirm the reported complaint, however without further information our investigation remains inconclusive, and a definitive root cause cannot be determined.Specific factors known to contribute to the alleged fault are excessive physical activity levels, unreasonable stress on replacement system, excessive patient weight, trauma to the joint replacement, loosening of components may increase production of wear particles and accelerate damage to the bone.Should the devices or additional information be received, the complaint will be reopened.Based on this investigation, the need for corrective and preventative actions is not indicated.
Additional Manufacturer Narrative
It was reported that a right hip revision surgery was performed on a bilateral patient due to pain and elevated cobalt levels in blood.Intraoperatively, a small amount of trunnionosis without damage to the stem was seen with no signs of metallosis.As of today, the implanted devices, all of which were used in treatment have not been returned for evaluation.A review of the historical complaints data for the hemi head and modular sleeve was performed using batch numbers, part numbers and the reported failure modes to evaluate patterns of repeated failures or defects.Similar complaints have been identified for devices concerned, however, as the devices are no longer sold, no action is to be taken.In the absence of the actual devices, the production records were reviewed for the devices reportedly involved in this incident.All released devices involved met manufacturing specifications upon release for distribution.The review of the products ifu found adequate warnings and precautions in relation to the alleged failure modes.A risk management review was performed.The alleged failure modes and associated risks have been anticipated within the risk file and the anticipated risk level is still adequate.No further actions are required at this time.A review of historic escalation actions related to the products and similar complaint events was performed.Following the review, prior applicable escalation actions were identified and confirmed to reduce associated risks as far as possible.No further escalation actions are required.The available medical documents were reviewed.The intraoperative reported noted, no soft tissue metallosis, bony ingrowth to cup, and mild trunnionosis.The clinical root cause of the reported pain, elevated metal ions, and trunnionosis cannot be confirmed, it cannot be concluded the reported clinical reactions were associated with a malperformance of the implant or implant failure.The patient impact beyond the pain, revision, and expected transient post-op convalescence period cannot be determined.Based on the available information our investigation remains inconclusive, and a definitive root cause cannot be determined.Specific factors known to contribute to the alleged fault are excessive physical activity levels, unreasonable stress on replacement system, excessive patient weight, trauma to the joint replacement, loosening of components may increase production of wear particles and accelerate damage to the bone.Should the devices or additional information be received, the complaint will be reopened.Based on this investigation, the need for corrective and preventative actions is not indicated.
Additional Manufacturer Narrative
Additional information: b5, b6, h10 h3, h6: it was reported that a right hip revision surgery was performed on a bilateral patient due to pain and elevated cobalt levels in blood.Intraoperatively, a small amount of trunnionosis without damage to the stem was seen with no signs of metallosis.As of today, the implanted device used in treatment has not been returned for evaluation.A review of the historical complaints data for the devices involved was performed, using batch number, part number and the reported failure mode to evaluate patterns of repeated failures or defects.Similar complaints have been identified for the devices; this will continue to be monitored via routine trending, however it should be noted that these devices are no longer sold.In the absence of the actual devices, the production records were reviewed for the parts reportedly involved in this incident.All released devices involved met manufacturing specifications upon release for distribution.The review of the product ifu found adequate warnings and precautions in relation to the alleged failure modes.A risk management review was performed.The alleged failure modes and associated risks have been anticipated within the risk files and the anticipated risk level is still adequate.No further actions are required at this time.A review of historic escalation actions related to the product and similar complaint events was performed.Following the review, prior applicable escalation actions were identified and confirmed to reduce associated risks as far as possible.No further escalation actions are required.The available medical documents were reviewed.Patient had bilateral r3 tha¿s.Revision indicators were noted as pain, low likelihood of infection, possibility of loosening of the acetabular component per bone scan, and elevating cobalt and chromium ions.Cobalt and chromium (b)(6) 2021 was 13.2 and 3.6 ng/ml respectively.¿ right hip aspiration (b)(6) 2022, yielded 5 ml clear yellow fluid, no afb, no organisms seen.Revision intraoperative findings were noted as, ¿no soft tissue metallosis, bony ingrowth to cup, and mild trunnionosis.¿ a physician¿s note indicated, the patient has ¿a significant numerous history of falls.¿ all documents and images provided as of this date have been reviewed and considered and unless noted do not contribute to the clinical/medical investigation.The intraoperative reported noted, "no soft tissue metallosis, bony ingrowth to cup, and mild trunnionosis." the clinical root cause of the reported pain,elevated metal ions, and trunnionosis cannot be confirmed, it cannot be concluded the reported clinical reactions were associated with a malperformance of the implant or implant failure.The patient impact beyond the pain, revision, and expected transient post-op convalescence period cannot be determined; however, post revision cobalt and chromium levels were 4.0 and 2.6 ng/ ml respectively.Based on the available information our investigation remains inconclusive, and a definitive root cause cannot be determined.Specific factors known to contribute to the alleged fault are excessive physical activity levels, unreasonable stress on replacement system, excessive patient weight, trauma to the joint replacement, loosening of components may increase production of wear particles and accelerate damage to the bone.Should the device or additional information be received, the complaint will be reopened.Based on this investigation, the need for corrective and preventative actions is not indicated.
Event or Problem Description
It was reported that, after a primary r3-tha construct had been implanted on the patient's right hip on (b)(6) 2010, the patient experienced pain and elevated cobalt levels in blood.A revision surgery was conducted on (b)(6) 2022 to address both symptoms.During this procedure, the modular head, the chrome-cobalt liner and the acetabular cup were explanted and replaced with a competitor¿s acetabular system and a smith and nephew femoral metallic head.As part of the intraoperative findings, no signs of metallosis were seen as well as no significant soft tissue destruction of the musculature was noted upon entering the capsule.The modular head was removed and noted to have a small amount of trunnionosis without damage to the stem.Although a preoperative bone scan suggested that the acetabular component was loose, intraoperatively it was denoted that this component showed good bony ingrowth.The patient was awoken form anesthesia and transferred to the recovery room in stable condition.Latest test results on (b)(6) 2022 showed a reduction of metals in blood (chromium = 2.6 ng/ml, cobalt = 4.0 ng/ml).
Additional Manufacturer Narrative
H3, h6: it was reported that a right hip revision surgery was performed on a bilateral patient due to pain and elevated cobalt levels in blood.Intraoperatively, a small amount of trunnionosis without damage to the stem was seen with no signs of metallosis.As of today, the implanted device used in treatment has not been returned for evaluation.A review of the historical complaints data for the devices involved was performed, using batch number, part number and the reported failure mode to evaluate patterns of repeated failures or defects.Similar complaints have been identified for the devices; this will continue to be monitored via routine trending, however it should be noted that these devices are no longer sold.In the absence of the actual devices, the production records were reviewed for the parts reportedly involved in this incident.All released devices involved met manufacturing specifications upon release for distribution.The review of the product ifu found adequate warnings and precautions in relation to the alleged failure modes.A risk management review was performed.The alleged failure modes and associated risks have been anticipated within the risk files and the anticipated risk level is still adequate.No further actions are required at this time.A review of historic escalation actions related to the product and similar complaint events was performed.Following the review, prior applicable escalation actions were identified and confirmed to reduce associated risks as far as possible.No further escalation actions are required.The available medical documents were reviewed.It should be noted the implantation operative report indicated the acetabular component was implanted in 40 degrees of abduction and 10 degrees of anteversion.As well, the revision operative report noted, ¿the cup was in good overall position slightly neutral in anteversion.¿.However, the surgical technique (r3 acetabular system 71381395 rev0 02/10) indicates, ¿approximately 45° of abduction and 20° of anteversion for final position of the acetabular component.¿.The reported pain, elevated metal ions and intraoperative findings of dark gray discoloration and trunnion corrosion may be consistent with the reported metallosis.However, the clinical root cause of the reported clinical reactions cannot be confirmed.It cannot be concluded the reported clinical reactions were associated with a malperformance of the implant.The patient impact beyond the reported pain, revision, and expected transient post-op convalescence period cannot be determined; however, 3-months post revision cobalt and chromium were 2.2 and 2.9 ng/ ml respectively.Based on the available information our investigation remains inconclusive, and a definitive root cause cannot be determined.Specific factors known to contribute to the alleged fault are excessive physical activity levels, unreasonable stress on replacement system, excessive patient weight, trauma to the joint replacement, loosening of components may increase production of wear particles and accelerate damage to the bone.Should the device or additional information be received, the complaint will be reopened.Based on this investigation, the need for corrective and preventative actions is not indicated.
Additional Manufacturer Narrative
Corrected data: b5, b6, b7, e1, g2, h6 (health effect - clinical code, health effect - impact code, medical device problem code).
Event or Problem Description
It was reported that, after a primary r3-tha construct had been implanted on the patient's right hip on (b)(6) 2010, the patient experienced pain and elevated cobalt levels in blood.A revision surgery was conducted on (b)(6) 2022 to address both symptoms.During this procedure, the modular head was explanted and replaced.As part of the intraoperative findings, no signs of metallosis were seen as well as no significant soft tissue destruction of the musculature was noted upon entering the capsule.The modular head was removed and noted to have a small amount of trunnionosis without damage to the stem.Although a preoperative bone scan suggested that the acetabular component was loose, intraoperatively it was denoted that this component showed good bony ingrowth.The patient was awoken form anesthesia and transferred to the recovery room in stable condition.Latest test results on (b)(6) 2022 showed a reduction of metals in blood (chromium = 2.8 ng/ml, cobalt = 5.0 ng/ml).

• Brand Name: HEMI HEAD 46MM
• Common Device Name: PROSTHESIS, HIP, HEMI-, FEMORAL, METAL
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house, spa park; leamington spa warwickshire CV31 3HL; UK CV31 3HL
• Manufacturer (Section G): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house, spa park; leamington spa warwickshire CV31 3HL; UK CV31 3HL
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 15785907
• Report Number: 3005975929-2022-00486
• Device Sequence Number: 19585790
• Product Code: KWL
• UDI-Device Identifier: 00885556071588
• UDI-Public: 885556071588
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K062408
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 07/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/29/2013
• Device Catalogue Number: 74122546
• Device Lot Number: 08LW20088
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/09/2022
• Supplement Date Received by Manufacturer: 12/20/2022; 01/19/2023; 03/30/2023; 06/29/2023; 07/17/2023
• Initial Report FDA Received Date: 11/12/2022
• Supplement Report FDA Received Date: 12/27/2022; 01/24/2023; 04/04/2023; 07/11/2023; 07/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2008
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PN: 71306113 / LOT: 09LM04144; PN: 71335558 / LOT: 09KM09263A; PN: 71336535 / LOT: 08FT21156; PN: 71336535 / LOT: 09ET31847; PN: 74222200 / LOT: 09BW22218
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 92 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White