MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD BHR ACETABULAR CUP 58MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 74121150

Device Problems Device Operates Differently Than Expected (2913); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Failure of Implant (1924); Toxicity (2333)

Event Date 04/27/2015

Event Type  Injury  

Event Description

It was reported the left hip revision surgery was performed due to failed hip arthroplasty and metallosis.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

This complaint was reopened following receipt of additional information.It was reported the left hip revision surgery was performed due to failed hip arthroplasty and metallosis.During the revision the bhr head was removed.The bhr cup remains implanted.As of today, device return and additional information has been requested for this revision complaint but has not become available.Using the supplied implantation dates, hospital name and implanting surgeon's name, the devices part numbers involved in this case have been preliminarily identified (subject to confirmation with medical records).The devices identified were as follows: 74120158, 089991 acetlr cup hap 58mm w/ imptr: 74121150, 085372 resurfacing femoral head 50mm: in the absence of the actual devices, the production records were reviewed for the devices identified above believed to be involved in this event.Device history record review confirmed that all released parts met specifications applicable at the time of production.The available medical documentation was reviewed.This patient underwent a right bhr revision 5 years post implantation, due to report of metallosis with high cobalt and chromium levels, and fluid collection seen on mri with a progressive cyst over the supraacetabular area.The surgical revision report states that intraoperatively cultures were obtained and sent for frozen section biopsy, which subsequently came back no acute inflammation.Additionally, the acetabular component appeared very well fixed.The report also states that two bone cysts were noted, and both were curetted, debrided and copiously irrigated.The acetabular cup was checked for ingrowth, and it was noted to be extremely well ingrown, and not felt to be a problem.Fluoroscopic images were obtained to check for completeness of fill of the bone cyst, as well as the accuracy of the leg length, and reportedly appeared good.Neither supporting intra-op findings/images nor pathology/lab results were provided to confirm the reported elevated cobalt and chromium levels.The clinical symptoms of the reported elevated cobalt and chromium levels, bone cyst, and reported "symptoms of metallosis" may be consistent with an adverse reaction to metal debris, but this cannot be confirmed based on the information provided.The source of the reported elevated cobalt and chromium levels and metallosis cannot be determined.It was noted that use of a competitor's (stryker) dual mobility liner, femoral stem and femoral head devices were implanted with the bhr cup at the time of revision.This activity was performed contrary to the instructions for use of for bhr implants which states under its important medical information, "do not mix components from other manufacturers." 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: BHR ACETABULAR CUP 58MM
• 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: 7056695
• MDR Text Key: 92833035
• Report Number: 3005975929-2017-00405
• Device Sequence Number: 1
• Product Code: NXT
• 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: 08/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2013
• Device Catalogue Number: 74121150
• Device Lot Number: 85372
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/14/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 74120158/ACETLR CUP HAP 58MM W/ IMPTR/089991 /; FEMORAL HEAD, # 74121150, LOT # 085372; FEMORAL HEAD, PART AND LOT # UNKNOWN
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 52 YR