MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD R3 40MM ID US COCR LNR 52MM; R3 COCR ACETABULAR LINER

Catalog Number 71341152

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190); Appropriate Term/Code Not Available (3191)

Patient Problems Pain (1994); Synovitis (2094); Toxicity (2333); Injury (2348); Test Result (2695)

Event Date 04/04/2017

Event Type  Injury  

Event Description

It was reported that left hip revision surgery was performed due to pain, synovitis and elevated metal ion levels.

Manufacturer Narrative

As of today, device return and additional information has been requested for this complaint but has not become available.Since neither the underlying medical documents nor device part details were received for investigation no thorough medical investigation, manufacturing record review and assessment of the reported event can be performed.Without return of the actual devices or further information we cannot further investigate or confirm the details supplied in this complaint.If the products or additional information become available in the future, this case will be reopened.Without additional information about this patient¿s particular case, our investigation remains inconclusive.No preventative or corrective action has been initiated as a result of this investigation.

Manufacturer Narrative

It was reported that left hip revision surgery was performed.During the revision, the hemi head, modular sleeve and liner were removed.The r3 shell, stem, and threaded hole cover 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, r3 liner and hole cover was performed using batch numbers in search of similar recurring reports for the products during their lifetimes.A full complaint history could not be performed for the modular sleeve as no batch number has been provided.Therefore, a search of similar complaints, involving synovitis and elevated test results, was conducted for the part.No other similar complaints were identified for the liner, shell, hemi head and hole cover.Similar complaints have been identified for the modular sleeve and this failure 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.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 reported pain, synovitis, and elevated ions are consistent with metal debris but the revision note indicates no frank metallosis and normally articulating hip and the metal ions are only mildly elevated.Without the supporting pathology results, imaging or analysis of the explanted components, the root cause cannot be confirmed, and it cannot be concluded that the reported symptoms (pain, hearing loss, memory loss) are 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 40MM ID US COCR LNR 52MM
• Type of Device: R3 COCR ACETABULAR LINER
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house; spa park; leamington spa, warwickshire CV31 3HL; UK CV31 3HL
• MDR Report Key: 7850180
• MDR Text Key: 119336591
• Report Number: 3005975929-2018-00299
• 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: 03/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2012
• Device Catalogue Number: 71341152
• Device Lot Number: 08MW20423
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 74122540 HEMI HEAD, LOT 08CW16078; 74222200 MODULAR SLEEVE, LOT UNKNOWN.; ACET SHELL 52MM 71331852 LOT UNKNOWN.; ACETABULAR SHELL, PART AND LOT # UNKNOWN.; ANTHOLOGY SIZE 7 71356007 LOT UNKNOWN.; FEMORAL STEM, PART AND LOT # UNKNOWN.; HEMI HEAD, PART AND LOT # UNKNOWN.; HOLE COVER 71336500 LOT UNKNOWN.; MODULAR SLEEVE 74222200 LOT UNKNOWN.; MODULAR SLEEVE, PART AND LOT # UNKNOWN.; ACETABULAR SHELL, PART AND LOT # UNKNOWN; FEMORAL STEM, PART AND LOT # UNKNOWN; HEMI HEAD, PART AND LOT # UNKNOWN; MODULAR SLEEVE, PART AND LOT # UNKNOWN
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 61 YR