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

Patient Problems Inflammation (1932); Pain (1994); Swelling (2091); Toxicity (2333); Test Result (2695)

Event Date 02/11/2019

Event Type  Injury  

Event Description

It was reported that the patient had pain, inflammation, swelling and severe increase level metal ions.A revision surgery was performed due to failed left hip replacement.Revision surgery from the right hip reported to fda in mdr 3005975929-2019-00059.

Manufacturer Narrative

It was reported that left hip revision surgery was performed.During the revision, the bhr cup and bhr head were removed.As of today, the implanted devices, all of which were used in treatment, and additional information have been requested for this complaint but have not become available a review of the complaint history for the head / cup was performed using batch numbers in search of similar recurring reports for the products during their lifetimes.Similar complaints have been identified 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.All the released devices involved met manufacturing specifications 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 a result of the reported event.The available medical documents were reviewed.Although it was reported that the patient had increased metal ions, no units of measure or lab values were given nor was a laboratory report provided.The reported increased metal ions may be consistent with findings associated with metal debris.However, without the supporting lab/pathology results, imaging, and/or the analysis of the explanted components, the root cause of the reported elevated metal ion levels cannot be confirmed and it cannot be concluded that the reported clinical reactions were associated with a malperformance 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 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: 8432806
• MDR Text Key: 139212686
• Report Number: 3005975929-2019-00140
• 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: other
• Type of Report: Initial,Followup
• Report Date: 03/19/2020

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 Expiration Date: 05/31/2012
• Device Model Number: 74120152
• Device Catalogue Number: 74120152
• Device Lot Number: 75618
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/14/2019
• Initial Date FDA Received: 03/19/2019
• Supplement Dates Manufacturer Received: 03/14/2019
• Supplement Dates FDA Received: 03/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 74121146 HEAD, LOT 076219.; FEMORAL HEAD 46MM 74121146 LOT 076219.; FEMORAL HEAD 46MM 74121146, LOT 076219
• Patient Outcome(s): Hospitalization; Required Intervention