MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD HEMI HEAD 54MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Model Number	74122554
Health Effect - Clinical Codes	Pain (1994); Toxicity (2333); Limited Mobility Of The Implanted Joint (2671); Metal Related Pathology (4530)
Date of Event	02/07/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed on the patients left hip on (b)(6) 2019, due severe pain, limited mobility, metallosis, elevated cobalt and chromium levels, and trunnionosis.Among the intra-operative findings and diagnoses were: elevated cobalt and chromium levels, trunnionosis and metallosis as a result of the premature failure of the devices.The patient's outcome is unknown.
Additional Manufacturer Narrative
It was reported that left hip revision surgery was performed.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 cup and hemi head 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 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 was performed.No additional risks were identified as result of the reported event.The available medical documents were reviewed.Although the reported pain, elevated cobalt and chromium levels may be consistent with findings associated with trunnionosis and metal debris; however, without the supporting lab/pathology results, imaging, and/or the analysis of the explanted components, the root cause of the pain, elevated cobalt and chromium levels, and trunnionosis cannot be confirmed, and it cannot be concluded that the reported clinical reactions were associated with a mal-performance of the implant.The patient impact beyond the pain, revision, and expected transient post-op convalescence period cannot be determined.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: HEMI HEAD 54MM
• 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
• MDR Report Key: 10582549
• Report Number: 3005975929-2020-00357
• Device Sequence Number: 2779074
• Product Code: NXT
• UDI-Device Identifier: 00885556071854
• UDI-Public: 00885556071854
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P040033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/01/2020

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: No Information
• Device Expiration Date: 02/26/2013
• Device Model Number: 74122554
• Device Catalogue Number: 74122554
• Device Lot Number: 08BW15618
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/28/2020
• Supplement Date Received by Manufacturer: 11/25/2020
• Initial Report FDA Received Date: 09/24/2020
• Supplement Report FDA Received Date: 12/02/2020
• 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: SLEEVE 74222200, LOT 08BW15618; STEM 71357107, LOT 07KM23182A; SLEEVE 74222200, LOT 08BW15618; STEM 71357107, LOT 07KM23182A
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention