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 Codes	Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Injury (2348); Test Result (2695)
Date of Event	03/09/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that revision surgery was performed due to elevated metal ions levels.
Additional Manufacturer Narrative
It was reported that a hip revision surgery was performed.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.Without definitive part/lot numbers a complete complaint history review cannot be performed for the devices involved.A review of the complaint history review was performed using the part number for a 74122548 hemi head 48mm, 74222400 modular sleeve +8mm 12/14 & 74120154 acetlr cup 54mm in search of complaints involving elevated test results throughout the lifetime of the product.Similar complaints have been identified and this will continue to be monitored.No lot numbers were provided; hence a documentation review could not be completed.Without the details of the devices involved in this complaint, the specific product labelling and ifus for the devices cannot be reviewed.If this information becomes available at a later time, the task will be reopened and completed.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.No medical documents were received.Without the supporting lab results, imaging, medical reports and the analysis of the explanted components, the trunnionosis and metallosis cannot be confirmed and it cannot be concluded that the reported events reactions were associated with a malperformance of the implant.The patient impact beyond the 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 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: 9932406
• Report Number: 3005975929-2020-00099
• Device Sequence Number: 14376742
• Product Code: JDH
• UDI-Device Identifier: 00885556071847
• UDI-Public: 00885556071847
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/06/2020

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
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/10/2020
• Supplement Date Received by Manufacturer: 04/24/2020
• Initial Report FDA Received Date: 04/07/2020
• Supplement Report FDA Received Date: 05/06/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 74120154 ACETLR CUP HAP 54MM W/ IMPTR.; 74222400 MODULAR SLEEVE +8MM 12/14.; MODULAR SLEEVE, # 74222400, LOT # UNKNOWN.; UNKN01102100 UNKN BHR IMP.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention