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

Catalog Number 74120152

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Noise, Audible (3273)

Patient Problems Pain (1994); Toxicity (2333); Injury (2348); Osteopenia/ Osteoporosis (2651); Test Result (2695)

Event Date 04/02/2013

Event Type  Injury  

Event Description

It was reported a left hip revision surgery due to persistent pain, heard popping of the device, metallosis, bone loss and elevated test results.

Manufacturer Narrative

It was reported that left hip revision surgery was performed.During the revision, the acetabular cup, modular sleeve and hemi head were removed.The anthology stem 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 head / cup / sleeve / stem 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 and stem.Similar complaints have been identified for the cup and sleeve 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.The available medical documents were reviewed.Although it was reported the patient had elevated cobalt and chromium serum levels, neither the levels nor the lab reports were provided for review.The reported pain, elevated metal ions along with intraoperative findings of black stained hypertrophic synovium, bone loss and fluid within the joint may be consistent with findings of metallosis and synovitis.However, without the supporting lab/pathology results, imaging, and/or the analysis of the explanted components, the root cause of the reported pain, synovitis, and elevated metal ion levels 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 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 re-opened.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 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: 9309327
• MDR Text Key: 165974757
• Report Number: 3005975929-2019-00397
• 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: 09/30/2013
• Device Catalogue Number: 74120152
• Device Lot Number: 094967
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/15/2019
• Initial Date FDA Received: 11/12/2019
• Supplement Dates Manufacturer Received: 04/24/2020; 08/18/2020
• Supplement Dates FDA Received: 05/06/2020; 10/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 71309009 SYN POR PLUS HA SO STEM SZ 9 09FM06302A; 74122546 HEMI HEAD 46MM 08KW19410; 74222100 MODULAR SLEEVE -4MM 12/14 08EW16958
• Patient Outcome(s): Hospitalization; Required Intervention