MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD FEMORAL HEAD 44MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Model Number	74123144
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Code	Metal Related Pathology (4530)
Date of Event	10/15/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal reference number: (b)(4).
Event or Problem Description
It was reported that, after right bhr in (b)(6) 2010, the plaintiff has suffered of severe pain, metallosis, adverse local tissue reaction, brown synovium consistent with pseudotumor and loosening of the femoral component.Plaintiff underwent a revision surgery on (b)(6) 2019.The femoral head was explanted and, as the cup was well fixed in place, it was left inside the patient.The patient was brought to the post anesthesia care unit in stable condition.
Additional Manufacturer Narrative
H3, h6: it was reported that a revision surgery was performed on the patient¿s right hip.The bhr cup used in the treatment remains implanted and therefore cannot be evaluated.The bhr head used in treatment was removed.As of today, additional information and device return has been requested for this complaint but has not become available.A review of the historical complaints data for the cup and head was performed.Using batch numbers to evaluate patterns of repeated failures or defects over the lifetime of the product.No other similar complaints were identified for the cup or head.A search was also performed using part numbers and the reported failure modes to evaluate patterns of repeated failures or defects in a timeframe of 12 months prior to the date in which the incident was reported.Other similar complaints were identified for the cup and head.However, as bhr systems of this size are no longer sold, no action is to be taken.All the released devices involved met manufacturing specifications at the time of production.Review of the product ifu found adequate warnings and precautions in relation to the alleged failure modes.A risk management review could not be performed for the head or cup as these devices 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.Following the review, prior applicable escalation actions were identified and confirmed to reduce associated risks as far as possible; no further escalation actions required.The available medical information was reviewed.The clinical information provided of the brown synovium consistent with pseudotumor and loose femoral component 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 additional information we cannot further investigate or confirm the reported complaint.The investigation remains inconclusive, and a definitive root cause cannot be determined.Additionally, specific factors known to contribute to the alleged fault cannot be provided due to the insufficient information.If the products or additional information become available in the future, this case will be reopened.Based on this investigation, the need for corrective or preventative action is not indicated.

• Brand Name: FEMORAL HEAD 44MM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
• 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; austin, TX 78735 ; 5123913905
• MDR Report Key: 13084423
• Report Number: 3005975929-2021-00577
• Device Sequence Number: 12118044
• Product Code: NXT
• UDI-Device Identifier: 03596010552419
• UDI-Public: 03596010552419
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: P040033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/09/2022

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 Model Number: 74123144
• Device Catalogue Number: 74123144
• Device Lot Number: 08KW19281
• 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: 11/29/2021
• Supplement Date Received by Manufacturer: 03/06/2022
• Initial Report FDA Received Date: 12/24/2021
• Supplement Report FDA Received Date: 03/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female