MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD ACETLR CUP HAP 48MM W/ IMPTR; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 74120148

Device Problems Appropriate Term/Code Not Available (3191); Patient Device Interaction Problem (4001)

Patient Problems Pain (1994); Injury (2348)

Event Date 07/31/2019

Event Type  Injury  

Event Description

It was reported that a revision was performed due to persistent pain.

Manufacturer Narrative

It was reported that right hip revision surgery was performed.During the revision, the cup, head stem and sleeve 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 acetabular cup, hemi head, stem and modular 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 acetabular cup, hemi head and stem.Similar complaints have been identified for the modular sleeve.However, as the device is no longer sold, no action is to be taken.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.No further actions are required at this time.The available medical documents were reviewed.The patient¿s reported persistent pain may be consistent with an adverse reaction to metal debris, but this cannot be confirmed based on the limited information provided.Without the supporting revision operative report, post-primary radiographic images, revision lab/pathology results, and/or the analysis of the explanted components, the root cause of the reported clinical symptoms cannot be confirmed and it cannot be concluded that the reported clinical reactions were associated with a mal-performance of the implant.The patient impact beyond the revision and associated post-op pain cannot be determined, and there is no report of the patient¿s current condition, or whether the reported clinical symptoms persist.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 48MM 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: 9548769
• MDR Text Key: 173653896
• Report Number: 3005975929-2020-00001
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/30/2013
• Device Catalogue Number: 74120148
• Device Lot Number: 089472
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/06/2019
• Initial Date FDA Received: 01/03/2020
• Supplement Dates Manufacturer Received: 07/02/2020; 08/18/2020
• Supplement Dates FDA Received: 07/07/2020; 10/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 71356103 ANTH HO PO SZ 3 09LM11606; 74122542 HEMI HEAD 42MM 08FW17356; 74222200 MOD SLEEVE P 0MM 12/14 09BW22223
• Patient Outcome(s): Hospitalization; Required Intervention