MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD HEMI HEAD 48MM; PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL

Model Number	74122548
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Injury (2348); No Known Impact Or Consequence To Patient (2692)
Date of Event	10/03/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Left hip revision surgery was performed due to mechanical complications.
Additional Manufacturer Narrative
It was reported that left hip revision surgery was performed.During the revision the hemi head & modular sleeve were removed.The acetabular cup & stem remained implanted.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 head / cup / sleeve was performed using batch numbers in search of similar recurring reports for the products during their lifetimes.Similar complaints have been identified for the head/ sleeve/cup 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 intraoperative findings of the reported stained tissue and fluid are consistent with findings associated with metal debris; however, without all supporting imaging, and the analysis of the explanted components, the root cause of the reported mechanical failure of the device and other symptoms noted in the legal claim cannot be confirmed, and it cannot be concluded that the reported reactions were associated with a mal-performance of the implant.The patient impact beyond the revision and post-operative healing 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 48MM
• Common Device Name: PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house; spa park; leamington spa CV31 3HL; UK CV31 3HL
• MDR Report Key: 8381151
• Report Number: 3005975929-2019-00091
• Device Sequence Number: 16221545
• Product Code: JDH
• UDI-Device Identifier: 00885556071847
• UDI-Public: 00885556071847
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: 2017
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/14/2020

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 Model Number: 74122548
• Device Catalogue Number: 74122548
• Device Lot Number: 08JW18949
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/26/2019
• Supplement Date Received by Manufacturer: 02/26/2019
• Initial Report FDA Received Date: 03/01/2019
• Supplement Report FDA Received Date: 04/14/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ACETABULAR CUP, # 74122154, LOT # 08LW20217; FEMORAL STEM, # 71341016, LOT # 09EM17861; MODULAR SLEEVE, # 74222200, LOT # 09AW20997; ACETABULAR CUP, # 74122154, LOT # 08LW20217; FEMORAL STEM, # 71341016, LOT # 09EM17861; MODULAR SLEEVE, # 74222200, LOT # 09AW20997
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 66 YR