MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD ACETLR CUP HAP 52MM W/ IMPTR; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Model Number 74120152

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Toxicity (2333); Test Result (2695)

Event Date 09/10/2015

Event Type  Injury  

Event Description

It was reported that right hip revision surgery was performed due to elevated metal ion levels.Stem in situ.

Manufacturer Narrative

It was reported that right hip revision surgery was performed on a bilateral patient.During the revision, the acetabular cup, hemi head & modular sleeve were removed.The stem remained implanted.As of today, the implanted devices, all of which were used in treatment, and additional information has been requested for this complaint but has not become available.A review of the complaint history for the cup / head / sleeve was performed using batch numbers in search of similar recurring reports for the products during their lifetimes.No other similar complaints were identified for the head.Similar complaints have been identified for the cup + sleeve and this failure will continue to be monitored.In the absence of the actual devices, the production records were reviewed for the devices reportedly involved in this incident.Device history record review confirmed that all released parts met specifications applicable at the time of production.Review of the product ifu found adequate warnings and precautions in relation to the alleged failure modes.A risk management review was performed.No additional risks were identified as result of the reported event.The available medical documents were reviewed.The intraoperative findings of the reported elevated metal ion levels and necrosis may be consistent with findings associated with metal debris.However, without complete supporting medical documentation, the root cause of the reported symptoms noted in the legal claim cannot be concluded and it cannot be concluded that the reported reactions were associated with a mal-performance of the implant.The patient impact beyond the revision and expected post-operative pain 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 52MM 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: 9096685
• MDR Text Key: 161797909
• Report Number: 3005975929-2019-00345
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 03596010502575
• UDI-Public: 03596010502575
• Combination Product (y/n): N
• PMA/PMN Number: P040033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 01/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 74120152
• Device Catalogue Number: 74120152
• Device Lot Number: 078949
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/17/2019
• Initial Date FDA Received: 09/20/2019
• Supplement Dates Manufacturer Received: 09/17/2019
• Supplement Dates FDA Received: 01/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FEMORAL STEM 71356004/ 06MM03549.; HEMI HEAD 46MM 74122546/ 10034.; MODULAR SLEEVE 74222200/ 07KW14228.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 68 YR