MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD ACETLR CUP HAP 50MM W/ IMPTR; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 74120150

Device Problems Corroded (1131); Mechanical Problem (1384); Pitted (1460); Appropriate Term/Code Not Available (3191)

Patient Problems Osteolysis (2377); No Known Impact Or Consequence To Patient (2692); Test Result (2695)

Event Date 12/01/2016

Event Type  Injury  

Event Description

It was reported a right hip revision due to mechanical failure and corrosion.

Manufacturer Narrative

It was reported that right hip revision surgery was performed.During the revision the bhr cup, modular head and sleeve were removed.The synergy stem was retained.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.Review of manufacturing records did not reveal any waivers, concessions, manufacturing or material abnormalities that could have contributed to this issue.The available medical documents were reviewed.The reported pain, increased cobalt and chromium levels and heterotopic ossification with corrosion at both the inner portion of the acetabular head and the trunnion are associated metallosis and osteolysis.Pathological results of explanted components consist of gross description only.The root cause for the ¿heterotopic ossification¿ cannot be concluded but some patients can be genetically predisposed.It is a known complication of joint surgeries and is related to the procedure and not the device.Without the supporting lab/pathology results, imaging, and/or the analysis of the explanted components the source of reactions cannot be confirmed, and it cannot be concluded that the reported clinical reactions were associated with a mal-performance of the implant.The patient impact beyond the pain, 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: ACETLR CUP HAP 50MM W/ IMPTR
• 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: 9183964
• MDR Text Key: 162499857
• Report Number: 3005975929-2019-00360
• 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: other
• Type of Report: Initial,Followup
• Report Date: 12/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 06/30/2013
• Device Catalogue Number: 74120150
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/12/2019
• Patient Sequence Number: 1
• Treatment: HEAD 74122542, LOT 08JW18945; SLEEVE 74222100, LOT 08KW19683
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR