MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD R3 46MM ID US COCR LNR 58MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 71341158

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Local Reaction (2035); Injury (2348); Limited Mobility Of The Implanted Joint (2671)

Event Date 08/29/2018

Event Type  Injury  

Event Description

It was reported that a revision surgery from the right hip severe pain, metallosis, adverse local tissue reaction, trunnionosis, need for revision surgery, ongoing pain and suffering, and limited mobility.

Manufacturer Narrative

It was reported that hip revision surgery was performed.During the revision, the hemi head, modular sleeve and r3 liner were removed.The bhr cup and 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 r3 shell, r3 liner, hemi head 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 r3 shell and r3 liner.Similar complaints have been identified for the hemi head and modular sleeve.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.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 a result of the reported event.The available medical documents were reviewed.It cannot be determined to what extent the patient¿s daily cocaine and marijuana usage had on his pain and clinical status.Per the surgical technique, the acetabular component is to be impacted with 15-20° of anteversion and 40-45° inclination angle.However, the intraoperative report and x-ray indicated the acetabular component was implanted at approximately 25-33° anteversion.It is unknown if the increased anteversion of the acetabular component led to accelerated wear and metallosis.Without the supporting lab/pathology results or analysis of the explant, the root cause of the reported pain, and trunnionosis 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 reopened.No preventative or corrective action has been initiated as a result of this investigation.

• Brand Name: R3 46MM ID US COCR LNR 58MM
• 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: 8296832
• MDR Text Key: 134729992
• Report Number: 3005975929-2019-00047
• 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
• Report Date: 02/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2019
• Device Catalogue Number: 71341158
• Device Lot Number: 09AW21133
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ANTHOLOGY 71357009 LOT 11AM05767A; HEMI HEAD 46MM 74122546 LOT 08KW19323; MODULAR SLEEVE 74222200 LOT 10ET42416; R3 SHELL 58MM 71331858 LOT 10EM00531; ANTHOLOGY 71357009 LOT 11AM05767A; HEMI HEAD 46MM 74122546 LOT 08KW19323; MODULAR SLEEVE 74222200 LOT 10ET42416; R3 SHELL 58MM 71331858 LOT 10EM00531
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 60 YR