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

Catalog Number 74122546

Device Problem Biocompatibility (2886)

Patient Problems Failure of Implant (1924); Metal Related Pathology (4530)

Event Date 01/11/2021

Event Type  Injury  

Event Description

It was reported that after a first right hip revision surgery performed on (b)(6) 2009 (covered in case-(b)(4)), the patient had a right hip failure.A second revision surgery was performed on (b)(6) 2021 to address this issue.During the revision, significant metallosis was found in the hip.The outcome of the patient is unknown.

Manufacturer Narrative

Internal complaint reference (b)(4).

Manufacturer Narrative

It was reported that a right hip revision surgery was performed.As of today, the implanted devices, all of which were used in treatment have not been returned for evaluation.Since part/lot details were not received for the acetabular cup for investigation no thorough manufacturing record review can be performed.If the products or additional information become available in the future, the tasks will be reopened and performed.A review of the historical complaints data for the hemi head and sleeve was performed.Using batch numbers to evaluate patterns of repeated failures or defects over the lifetime of the product and using part numbers and the reported failure modes to evaluate patterns of repeated failures or defects in a timeframe prior 12 months as of the complaint aware date.Other similar complaints were identified to involve this batch for the hemi head and sleeve.Other similar complaints have been identified for the part number and the reported failure mode for the hemi head.However, as devices are no longer sold, no action is to be taken.No other similar complaints have been identified for the part number and the reported failure mode for the sleeve.In the absence of the actual devices, the production records were reviewed for the known devices reportedly involved in this incident.Review of manufacturing records did not reveal any waivers, concessions, manufacturing or material abnormalities that could have contributed to this issue.All the released devices involved met manufacturing specifications upon release for distribution.Review of the product ifu found adequate warnings and precautions in relation to the alleged failure modes.The =46mm bhr resurfacing system, hemi heads, sleeves have been phased out from the market and as a result there is no live risk management file to review.Therefore, an evaluation of failure modes is not required.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.The available medical documents were reviewed.With the information provided the clinical root cause of the reported metallosis cannot be confirmed and it cannot be concluded the metallosis was associated with malperformance of the implant or implant failure.The patient impact beyond the revision and expected transient post-op convalescence period cannot be determined.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.Internal reference number.

Manufacturer Narrative

Additional information added: a2 (age at time of events & dob), b6, b7, d10 (concomitants added).Corrected data: b5(narrative), h6 (health effect - clinical code).

Event Description

It was reported that after a first right hip revision surgery performed on (b)(6) 2009, the patient presented persistent pain, discomfort on the lateral border of the right hip.A second revision surgery was performed on (b)(6) 2021 to address this issue.During the revision, significant metallosis was found in the hip and a debridement was performed.The modular head-sleeve and the acetabular cup were explanted and replaced with a competitor¿s system.The patient was later discharged and initiated physical therapy.

Manufacturer Narrative

H3, h6: it was reported that a right hip revision surgery was performed due to persistent pain, discomfort on the lateral border of the right hip and significant 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 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 hemi head, but not for the sleeve.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 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 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.With the information provided the clinical root cause of the reported metallosis cannot be confirmed and it cannot be concluded the metallosis was associated with malperformance of the implant or implant failure.The patient impact beyond the revision and expected transient post-op convalescence period cannot be determined.Based on the information provided, further investigation of the reported complaint cannot be carried out and remains inconclusive.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 46MM
• Type of Device: 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: 13094460
• MDR Text Key: 282821509
• Report Number: 3005975929-2021-00587
• Device Sequence Number: 1
• Product Code: KWL
• UDI-Device Identifier: 00885556071588
• UDI-Public: 885556071588
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062408
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/30/2013
• Device Catalogue Number: 74122546
• Device Lot Number: 08MW20403
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/31/2008
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Treatment: 71306614/SYN POR FEM COMP SZ 14; 74222200/MODULAR SLEEVE {} PLUS 0MM 12/14; PN: 71306614 / LOT: 10KM18269; PN: 74222200 / LOT: 10CT40671
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Weight: 84 KG