MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD R3 44MM ID US COCR LNR 56MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 71341156

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

Patient Problems Pain (1994); Toxicity (2333); Osteolysis (2377); Limited Mobility Of The Implanted Joint (2671)

Event Date 06/25/2018

Event Type  Injury  

Event Description

It was reported that an r3 mom revision surgery was performed on left hip due to severe pain, limited mobility, elevated cobalt and chromium levels, and metallosis.Bilateral patient, there's no confirmation of any medical procedure or surgical intervention for right hip.(b)(4).

Manufacturer Narrative

It was reported that left hip revision surgery was performed.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 liner, r3 shell, hemi head, modular sleeve, stem, modular stem neck and threaded hole cover 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 liner, r3 shell, hemi head, stem, modular stem neck and threaded 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 a result of the reported event.The available medical documents were reviewed.The clinical information provided, of the elevated metal ion levels, the dark tinging on the synovium, the trunnionosis and, the massive osteolysis, may be consistent with a reaction to metal debris.However, the source and the root cause cannot be determined with the available documentation.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 44MM ID US COCR LNR 56MM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house; spa park; leamington spa CV313 HL; UK CV313HL
• MDR Report Key: 8191145
• MDR Text Key: 131210309
• Report Number: 3005975929-2018-00549
• 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: 02/14/2020

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: Health Professional
• Device Expiration Date: 12/31/2018
• Device Catalogue Number: 71341156
• Device Lot Number: 08MW20459
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/17/2018
• Initial Date FDA Received: 12/21/2018
• Supplement Dates Manufacturer Received: 12/22/2008
• Supplement Dates FDA Received: 02/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 71331856 R3 ACET SHELL, LOT 10CM11029; 71336500 HOLE CO LOT 10BM07962; 71352116 MODULAR NECK, LOT 09GTM0010B; 71352502 SMF STEM, LOT 10BTM0008B; 7412254 4HEMI HEAD, LOT 08EW17143; 74222400 MODULAR SLEEVE, LOT 07JW14062; UNKNOWN BHR DEVICE/ UNKNOWN LOT; UNKNOWN BHR DEVICE/ UNKNOWN LOT
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 54 YR