MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD HEMI HEAD 50MM; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL

Catalog Number	74122550
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Code	Metal Related Pathology (4530)
Date of Event	05/21/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after a bhr tha left hip construct had been implanted on (b)(6) 2009, the plaintiff experienced an elevated ion levels and adverse local tissue reaction.A revision surgery was performed on (b)(6) 2019 to treat these adverse events.During surgery, it was noticed that the external rotators as well as posterior capsule were atrophied and yellowed.There was clearly trunnion corrosion with blackened material.The cup, the hemi head and the metal sleeve were explanted.The patient outcome is unknown.
Additional Manufacturer Narrative
H3, h36: it was reported that left hip revision surgery was performed.During the revision, the bhr cup, hemi head and modular sleeve were removed.The stem remained implanted.As of today, the implanted devices, all of which were used in treatment, and additional information have been requested for this complaint but have not become available.A review of the complaint history for the bhr cup, hemi head, modular sleeve and stem was performed using batch numbers in search of similar recurring reports for the products during their lifetimes.No other similar complaints were identified.In the absence of the actual devices, the production records were reviewed for the devices reportedly involved in this incident.All of the devices met manufacturing specifications at the time of production.No waivers, concessions, manufacturing or material abnormalities would have contributed to this issue.Review of the product ifu found adequate warnings and precautions in relation to the alleged failure modes.A risk management review was performed.No additional risks were identified as result of the reported event and no further actions are required at this time.The available medical documents were reviewed.The clinical information provided of elevated metal ions, necrosis, trunnion corrosion and blackened material may be consistent with a reaction to metal debris.However, the source and the root cause cannot be determined with the available documentation.It cannot be concluded that the reported clinical findings are associated with the implant failure.Without return of the actual devices or further information we cannot further investigate or confirm the details supplied in this complaint.The investigation remains inconclusive and a definitive root cause cannot be determined.Due to insufficient information, specific factors known to contribute to an alleged fault cannot be determined.If the products or additional information become available in the future, this case will be reopened.No preventative or corrective action has been initiated as a result of this investigation.
Additional Manufacturer Narrative
H10: additional information in b6 and b7.
Additional Manufacturer Narrative
H3, h6: it was reported that left hip revision surgery was performed due to elevated ion levels and adverse local tissue reaction.During the revision, the bhr cup, hemi head and modular sleeve were removed.The femoral stem remained implanted.As of today, the implanted devices, all of which were used in treatment , have not been returned for analysis.A review of the complaint history for the bhr cup, hemi head, modular sleeve and stem was performed using batch numbers in search of similar recurring reports for the products during their lifetimes.No other similar complaints were identified.A further review was performed for the part numbers and the reported failure mode to evaluate patterns of repeated failures or defects.Similar complaints have been identified for the hemi head and acetabular cup within the past year.This will continue to be monitored via routine trending, however it should be noted that the hemi head and modular sleeve are no longer sold.In the absence of the actual devices, the production records were reviewed for the devices reportedly involved in this incident.All of the devices met manufacturing specifications at the time of production.No waivers, concessions, manufacturing or material abnormalities would have contributed to this issue.Review of the product ifu found adequate warnings and precautions in relation to the alleged failure modes.A risk management review was performed.No additional risks were identified as result of the reported event.The alleged failure modes and associated risks have been anticipated within the risk file and the anticipated risk level is still adequate.A review of historical corrective and preventive actions, preliminary risk assessment, health hazard evaluations, and field 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.Per the surgical technique, the acetabular component is to be impacted with 15-20 degree of anteversion and 40-45 degree inclination angle.However, the revision report indicated that the acetabular component was in ¿approximately 51 degrees of abduction and 30 degrees of anteversion¿.It is unknown if this position of the acetabular component was a migration since implantation and if led to accelerated wear along with the pain, elevated metal ion levels, and intraoperative findings of significant tissue damage, atrophied and yellowed external rotators and posterior capsule- consistent with necrosis, and trunnion corrosion between the stem and femoral head with blackened material.It cannot be concluded that the reported clinical reactions were associated with a mal-performance of the implant or implant failure.The patient continued to have pain and weakness two years post revision.However, the surgeon indicated it is a possibility of referred pain due to the patient¿s history of multilevel spinal stenosis.Based on the information provided, 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.

• Brand Name: HEMI HEAD 50MM
• Common Device Name: PROSTHESIS, HIP, HEMI-, FEMORAL, METAL
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house, spa park; leamington spa warwickshire
• Manufacturer (Section G): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house, spa park; leamington spa warwickshire
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 11810153
• Report Number: 3005975929-2021-00219
• Device Sequence Number: 19744548
• Product Code: KWL
• UDI-Device Identifier: 00885556071205
• UDI-Public: 885556071205
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K062408
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/29/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/30/2013
• Device Catalogue Number: 74122550
• Device Lot Number: 08KW19424
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 04/21/2021
• Supplement Date Received by Manufacturer: 06/11/2021; 03/27/2023; 05/26/2023
• Initial Report FDA Received Date: 05/11/2021
• Supplement Report FDA Received Date: 06/15/2021; 04/14/2023; 05/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/31/2008
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-2745-2015
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR
• Patient Sex: Male