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

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190); Appropriate Term/Code Not Available (3191)

Patient Problems Pain (1994); Synovitis (2094); Injury (2348)

Event Date 10/30/2017

Event Type  Injury  

Event Description

It was reported that a revision surgery was performed due to pain and other complications.Operative notes reportedly noted significant ill-colored brownish synovitis in patient's hip joint.

Manufacturer Narrative

It was reported that right hip revision surgery was performed due to pain and other complications.During the revision the hemi head and modular sleeve were removed.The femoral stem and bhr cup 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.According to the provided revision report, there was significant ill-colored, brownish synovitis.The final diagnosis was ¿metallurgy and metalware¿.Review of the provided implantation and revision report did not reveal any findings that could explain or might have contributed to the reported reasons for the revision.Without further details about the intra-operative findings (e.G.A histopathological analysis) or the revised implants available for analysis it remains also unclear whether the findings correspond to material loss from 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.

Manufacturer Narrative

It was reported that right hip revision surgery was performed.During the revision, the hemi head and modular sleeve were removed.The bhr 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.The available medical documents were reviewed.The revision operative report stated significant synovitis, and a complete synovectomy was performed.Twelve months after the right tha revision, the patient underwent a revision of the left mom tha for reported metallosis and metal wear.The manufacturer of the left mom implant is unknown.The intraoperative findings of metallosis, synovitis and metal wear are consistent with findings associated with metal debris.Without the supporting lab/pathology results, and/or the analysis of the explanted components, the source of the reported metallosis cannot be confirmed.Additionally, given the need for revision of the contralateral tha, it cannot be concluded that the reported events were associated with a mal-performance of the smith and nephew implants.The patient¿s wilson¿s disease could also impact the systemic metal ion levels.All the released devices involved met manufacturing specifications at the time of production.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: BHR ACETABULAR CUP
• 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: 7612848
• MDR Text Key: 111431139
• Report Number: 3005975929-2018-00207
• 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: 09/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/15/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ACETLR CUP HAP 60MM W/ IMPTR, 0000468636, 080177; FEMORAL STEM, PART AND LOT # UNKNOWN; HEMI HEAD, PART AND LOT # UNKNOWN; MODULAR SLEEVE +4MM 12/14, 0002003226, 9768; MODULAR SLEEVE, PART AND LOT # UNKNOWN; SYN POR HO FEM COM SZ 13, 71306113, 07JM18346; FEMORAL STEM, PART AND LOT # UNKNOWN; HEMI HEAD, PART AND LOT # UNKNOWN; MODULAR SLEEVE, PART AND LOT # UNKNOWN
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 61 YR