MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD ACETLR CUP HAP 60MM W/ IMPTR; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 74120160

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Fatigue (1849); Pain (1994); Toxicity (2333); Injury (2348)

Event Date 08/21/2019

Event Type  Injury  

Event Description

It was reported that a right hip revision was performed due to pain, fatigue, debris and elevated levels of metal ions in blood.

Manufacturer Narrative

It was reported that a right hip revision surgery was performed.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 was performed using batch numbers in search of similar recurring reports for the products during their lifetimes.No other complaints have been identified for the cup.Similar complaints have been identified for the head and this 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.Review of manufacturing records did not reveal any waivers, concessions, manufacturing or material abnormalities that could have contributed to this issue.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 and no further actions are required at this time.The medical documents were reviewed.Although metal ion levels were reported to be elevated they could be related to the contralateral hip, neither the lab values nor the lab reports were provided.The operative report did not note findings related to metal related pathology.The very vertical acetabular cup cannot be ruled out as a contributory factor the reported pain and elevated metal ions if they are due to wear but cannot be confirmed.Metal debris related pathology was not reported and cannot be confirmed.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.

Manufacturer Narrative

New information: g4, d4.

• Brand Name: ACETLR CUP HAP 60MM 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: 9699604
• MDR Text Key: 178760045
• Report Number: 3005975929-2020-00052
• 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,Followup
• Report Date: 10/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/30/2012
• Device Catalogue Number: 74120160
• Device Lot Number: 74749
• Date Manufacturer Received: 08/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 74121154 RESURF FEM HEAD 54MM 70133
• Patient Outcome(s): Hospitalization; Required Intervention