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 Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Necrosis (1971); Injury (2348); Reaction (2414)

Event Date 07/02/2019

Event Type  Injury  

Event Description

It was reported that revision surgery was performed 10 years after th revision surgery resulted in the following intra-operative findings and/or diagnoses: metallosis, metal toxicity, adverse tissue reaction, necrotic tissue around the pseudocapsule and trochanteric bursa, bursa itself was full of fluid, and extensive debridement was required to remove any thickened scar tissue and necrotic debris.

Manufacturer Narrative

Initial submission was made with incorrect manufacturing site code.Correct code is (b)(4).

Manufacturer Narrative

It was reported that right hip revision surgery was performed.During the revision, the hemi head, modular sleeve and stem were removed.The 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, hemi head, modular sleeve and 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 bhr cup, hemi head and stem.Similar complaints have been identified for the 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 known 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 and no further actions are required at this time.The available medical documents were reviewed.The reported pain and elevated cobalt, and intraoperative findings of scar tissue, necrotic debris and metal wear on the trunnion may be consistent with trunnionosis and metal debris; however, the root cause cannot be determined nor can it be concluded that the clinical reactions are associated with a mal-performance of the implant.The patient impact beyond the revision 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: 9974036
• MDR Text Key: 188089492
• Report Number: 1020279-2020-01315
• 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: 10/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 74120152
• Device Lot Number: 092903
• Date Manufacturer Received: 10/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 71306612 SYN POR FEM COMP SZ 12; 74121146 RESURFACING FEMORAL HEAD 46MM; 74222300 MODULAR SLEEVE +4MM 12/14; HEMI HEAD, # 74122546, LOT # 08EW17156; MODULAR SLEEVE, # 74222300, LOT # 9974; SYNERGY STEM, # 71306612, LOT # 07KM04928; 71306612 SYN POR FEM COMP SZ 12; 74121146 RESURFACING FEMORAL HEAD 46MM; 74222300 MODULAR SLEEVE +4MM 12/14
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 64 YR