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

Model Number	74122152
Health Effect - Clinical Codes	Pain (1994); Swelling (2091); Toxicity (2333); Test Result (2695)
Date of Event	08/08/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that right hip revision surgery was performed due to pain, elevated metal ion levels and pseudotumour.
Additional Manufacturer Narrative
It was reported that right hip revision surgery was performed.During the revision the femoral head & acetabular cup were removed.As of today, the implanted devices, all of which were used in treatment, and additional information has been requested for this complaint but has not become available.A review of the complaint history for the cup + head was performed using batch numbers in search of similar recurring reports for the products during their lifetimes.No other similar complaints were identified for the cup.Similar complaints have been identified for the head and this failure will continue to be monitored.In the absence of the actual devices, the production records were reviewed for the devices reportedly involved in this incident.Device history record review confirmed that all released parts met specifications applicable 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 was performed.No additional risks were identified as result of the reported event.The medical documents were reviewed.The clinical information provided, of the elevated metal ion levels and the pseudotumour may be consistent with a reaction to metal debris.However the source cannot be determined with the available documentation and not laboratory values were provided.Also the root cause for the ¿heterotopic ossification¿ cannot be concluded however it is a known complication of joint surgeries and is related to the procedure and not the device.Further, it cannot be concluded that the reported clinical reactions were associated with a mal-performance of the implant.Without supporting clinical documents a thorough investigation cannot be performed.Should information become available this complaint can be re-assessed.The impact to the patient other than the surgeries cannot be concluded.Without return of the actual devices or further information we cannot further investigate or confirm the details supplied in this complaint, and our investigation remains inconclusive.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.

• Brand Name: BIRMINGHAM HIP RESURFACING
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house; spa park; leamington spa CV31 3HL; UK CV31 3HL
• MDR Report Key: 8059016
• Report Number: 3005975929-2018-00428
• Device Sequence Number: 1991550
• Product Code: NXT
• UDI-Device Identifier: 03596010552280
• UDI-Public: 03596010552280
• 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: 2013
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2020

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: 12/31/2013
• Device Model Number: 74122152
• Device Catalogue Number: 74122152
• Device Lot Number: 08MW20920
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/26/2018
• Supplement Date Received by Manufacturer: 10/26/2018
• Initial Report FDA Received Date: 11/12/2018
• Supplement Report FDA Received Date: 02/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 74123144 FEMORAL HEAD, LOT 09AW21563.; FEMORAL HEAD, # 74123144, LOT # 09AW21563.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 44 YR