MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD R3 COCR LINER 52MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 71341152

Device Problems Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hypersensitivity/Allergic reaction (1907); Toxicity (2333); Injury (2348); Test Result (2695)

Event Date 06/21/2017

Event Type  Injury  

Event Description

It was reported that right hip revision surgery was performed.Metal allergy and reaction, elevated cobalt and chromium levels, moderate metal reaction in soft tissue surrounding femoral neck reported.Bilateral patient, left hip revision reported via mdr 3005975929-2018-00178.

Manufacturer Narrative

It was reported that right hip revision surgery was performed due to metal allergy and reaction, elevated cobalt and chromium levels and moderate metal reaction in soft tissue surrounding femoral neck reported.During the revision the hemi head, modular sleeve and r3 liner were removed.The r3 shell and femoral stem remain implanted.As of today, device return and additional information has been requested for this complaint but has not become available.In the absence of the actual devices, the production records were reviewed for the known 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.The available medical documents were reviewed.Review of the provided implantation report did not reveal any inconsistencies related to the surgical technique that could explain the later revision.According to the provided revision report, the patient was described as known for metal allergy and metal reaction problems from previous revision.After that revision her chromium and cobalt levels were increasing.Corresponding results were not provided.During the revision moderate metal reaction in the soft tissue mostly at the neck was noted.The cup showed some wear at the cup articulating surface, otherwise all components were in good position and fixation.Based on the provided documents further investigation of the circumstances leading to this revision cannot be performed.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

It was reported that right hip revision surgery was performed.During the revision, the hemi head, modular sleeve and r3 liner were removed.The r3 shell and synergy 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 hemi head, r3 shell, liner and sleeve was performed using batch numbers in search of similar recurring reports for the products during their lifetimes.No other similar complaints were identified.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.No further actions are required at this time.The available medical documents were reviewed.The reported elevated cobalt and chromium levels and the noted intraoperative findings of a metal reaction surrounding the neck of the prosthesis with wear of the articular surface 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 root cause of the reported elevated cobalt and chromium levels and metal debris cannot be confirmed, and it cannot be concluded that the reported 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 reopened.No preventative or corrective action has been initiated as a result of this investigation.

• Brand Name: R3 COCR LINER 52MM
• 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: 7544042
• MDR Text Key: 109227792
• Report Number: 3005975929-2018-00179
• 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: consumer,other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2018
• Device Catalogue Number: 71341152
• Device Lot Number: 08MW20478
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ACETABULAR SHELL, # 09DM21685, LOT # 09DM10988; ACETABULAR SHELL, #71335552, LOT # 09DM10988; FEMORAL STEM, # 71306112, LOT # 09DM21685; HEMI HEAD, # 74122540, LOT # 08EW17140; MODULAR SLEEVE, # 74222100, LOT # 08CW16005; ACETABULAR SHELL, # 09DM21685, LOT # 09DM10988; FEMORAL STEM, # 71306112, LOT # 09DM21685; HEMI HEAD, # 74122540, LOT # 08EW17140; MODULAR SLEEVE, # 74222100, LOT # 08CW16005
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 71 YR