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 Adverse Event Without Identified Device or Use Problem (2993); Noise, Audible (3273)

Patient Problems Pain (1994); Toxicity (2333); Injury (2348)

Event Date 07/01/2015

Event Type  Injury  

Event Description

It was reported that a revision surgery of left hip was performed due to pain, grinding of the hip implant and high metal levels in blood.

Manufacturer Narrative

It was reported that left hip revision surgery was performed due to pain, popping, grinding of the hip implant and high metal levels in blood.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.Only an implantation report was provided.Review of the provided implantation report did not reveal any inconsistencies related to the surgical technique that could explain the revision and the reported issues.Further information on the alleged issues was not provided and a thorough investigation is not possible 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: 7628475
• MDR Text Key: 111979108
• Report Number: 3005975929-2018-00231
• 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: 01/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2012
• Device Catalogue Number: 74120150
• Device Lot Number: 077698
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BHR FEMORAL HEAD/ UNKNOWN LOT NUMBER.; FEMORAL HEAD 74121142 LOT 078208; BHR FEMORAL HEAD/ UNKNOWN LOT NUMBER.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 43 YR