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 Codes	Failure of Implant (1924); Pain (1994); Metal Related Pathology (4530)
Date of Event	02/18/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
*us legal mdl* it was reported that, after a bhr-tha construct had been implanted on the plaintiff's left hip on an unknown date, the plaintiff experienced metallosis and increased pain.A revision surgery was performed on (b)(6) 2021 to treat this adverse event.The plaintiff outcome is unknown.
Additional Manufacturer Narrative
H3, h6: 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 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 for the bhr cup, hemi head and stem.Similar complaints have been identified for the modular sleeve.However, as the device is 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 the released devices involved met manufacturing specifications at the time of production.The manufacturing records did not reveal any waivers, concessions, manufacturing or material abnormalities that could 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 have been reviewed.The clinical information provided, of the elevated metal ion levels, pain, metal staining and significant wear around the bottom of the trunnion 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.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: 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 CV31 3HL; UK CV31 3HL
• MDR Report Key: 11913842
• Report Number: 3005975929-2021-00302
• Device Sequence Number: 17234548
• Product Code: KWL
• UDI-Device Identifier: 00885556071205
• UDI-Public: 885556071205
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K062408
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/04/2021

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: 10/29/2012
• Device Catalogue Number: 74122550
• Device Lot Number: 07KW14098
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/12/2021
• Supplement Date Received by Manufacturer: 11/03/2021
• Initial Report FDA Received Date: 06/01/2021
• Supplement Report FDA Received Date: 11/04/2021
• 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: 71930422/ECH PRIM STD 12/14 S14 CLRLS; 74222100/MODULAR SLEEVE -4MM 12/14
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 58 YR