MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD BHR ACETABULAR CUP 50MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 74122150

Device Problems Metal Shedding Debris (1804); Appropriate Term/Code Not Available (3191)

Patient Problems Failure of Implant (1924); No Code Available (3191)

Event Date 05/25/2012

Event Type  Injury  

Event Description

It was reported that right hip revision surgery was performed due to metallosis.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

It was reported that right hip revision surgery was performed due to metallosis.During revision the bhr cup and the bhr head were removed.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.Per the right hip revision/conversion operative note the post-op diagnosis was "failed right total hip arthroplasty" approximately 10.5 months post implantation with no supporting finding other than scar tissue noted over the capsule.Neither supporting intra-op findings/images nor pathology/lab results were provided in regards to the reported metallosis.No further clinically relevant supporting documentation was provided for inclusion in this medical investigation.Without the explanted components, radiological images, pathology, or other supporting documentation, the reported metallosis cannot be confirmed nor can the root cause for the revision be concluded.The patient impact beyond the right hip revision/conversion to tha within a year of bhr/implantation 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.

• Brand Name: BHR ACETABULAR CUP 50MM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house; spa park; leamington spa CV31 3HL; UK CV31 3HL
• MDR Report Key: 6816141
• MDR Text Key: 83461581
• Report Number: 3005975929-2017-00248
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 03596010552273
• UDI-Public: 03596010552273
• Combination Product (y/n): N
• PMA/PMN Number: P040033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup,Followup
• Report Date: 09/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2015
• Device Catalogue Number: 74122150
• Device Lot Number: 10GW28974
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/23/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FEMORAL HEAD, # 74123144, LOT # 08KW19281; FEMORAL HEAD, # 74123144, LOT # 08KW19281
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 56 YR