MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD HEMI HEAD44MM; PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL

Catalog Number	74122544
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Pain (1994); Toxicity (2333); Test Result (2695)
Date of Event	02/13/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that left hip revision surgery was performed due to metallosis.
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, device return and additional information has been requested for this complaint but has not become available.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 available medical documents were reviewed.The revision operative report documents; ¿present was a small amount of traditional white fluffy material that we see with metallosis and this was over the trochanter.In conclusion, the clinical information provided, of the elevated metal ion levels and pain, and clinical observations during the revision surgery, may be consistent with a reaction to metal debris.However, the source and the root cause cannot be determined with the available documentation.The root cause of the continued pain cannot be concluded with the information provided.Further, it cannot be concluded that the reported clinical reactions were associated with a mal-performance of the implant.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 HEAD44MM
• 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: 8225723
• Report Number: 3005975929-2019-00006
• Device Sequence Number: 2027442
• Product Code: NXT
• UDI-Device Identifier: 00885556070994
• UDI-Public: 00885556070994
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/10/2019

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 Catalogue Number: 74122544
• Device Lot Number: 08HW18277
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/21/2018
• Supplement Date Received by Manufacturer: 12/21/2018
• Initial Report FDA Received Date: 01/08/2019
• Supplement Report FDA Received Date: 12/10/2019
• 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: ACETABULAR CUP, # 74122150, LOT # 09BW21867.; FEMORAL STEM, # 71309012, LOT # 09DM02921A.; MODULAR SLEEVE, # 74222100, LOT # 08GW17829.; ACETABULAR CUP, # 74122150, LOT # 09BW21867; FEMORAL STEM, # 71309012, LOT # 09DM02921A; MODULAR SLEEVE, # 74222100, LOT # 08GW17829
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 63 YR