MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD ACETABULAR CUP HAP SIZE 48/54; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 74122154

Device Problem Compatibility Problem (2960)

Patient Problems Pain (1994); Injury (2348)

Event Date 12/23/2019

Event Type  Injury  

Event Description

It was reported that a revision surgery was performed on the patients right hip due to pain, elevated metal ions, adverse local tissue reaction to metal debris, and a large pseudotumor.The patient outcome is unknown.

Manufacturer Narrative

Additional information received by the manufacturer has identified that this event should be re-evaluated for mdr reporting.The new information states that this information has been already reported under 1020279-2020-03891, therefore, it was determined that this case does not meet the threshold for reporting and is a non-reportable event.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly and a further report submitted outlining both the event details and our investigations performed.

Manufacturer Narrative

It was reported that right hip revision surgery was performed.During the revision, the femoral head was removed.The acetabular cup remained implanted.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 bhr cup and bhr head 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.A similar complaint has been identified for the cup, however this is for the same patient/part.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 result of the reported event.The available medical documents were reviewed.Without the implantation and pre-revision x-rays, it cannot be determined if the neutral position of the acetabular; with basically no anteversion and the inferior position of the femoral neck was the initial anatomical placement or if the implants migrated post-op; however, this cannot be ruled out as contributory factors to the reported clinical reactions.The reported pain, elevated metal labs and intraoperative findings of the reported stained tissue and pseudotumor 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 source of reactions cannot be confirmed, and it cannot be concluded that the reported events/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: ACETABULAR CUP HAP SIZE 48/54
• 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: 10396433
• MDR Text Key: 202554239
• Report Number: 3005975929-2020-00291
• 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: 02/02/2021

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: 04/29/2015
• Device Catalogue Number: 74122154
• Device Lot Number: 10DW26933
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/17/2020
• Initial Date FDA Received: 08/12/2020
• Supplement Dates Manufacturer Received: 01/12/2020; 01/29/2021
• Supplement Dates FDA Received: 01/15/2021; 02/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention