MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD R3 50MM ID INTL COCR LINER 62MM; PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL

Catalog Number 71335862

Device Problem Compatibility Problem (2960)

Patient Problem Injury (2348)

Event Date 07/13/2020

Event Type  Injury  

Event Description

It was reported that patient has elevated metal ions cr 1.26 co 7.78 g/l.Currently meeting the metal ion levels threshold for a complaint (>7ppb).Update on 07/13/2020 shows levels starting cr 1.26 co 7.78 g/l.

Manufacturer Narrative

It was reported that in a clinical study the patient had elevated metal ions.The devices, all of which were used in treatment, remain implanted.As of today, additional information has been requested for this complaint but have not become available.A review of the complaint history for the r3 liner, r3 shell, modular head, modular sleeve and synergy 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 stem and shell.Similar complaints have been identified for the liner, head and 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 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.Smith and nephew has not received patient specific information or the adequate materials to fully evaluate the complaint, but if additional clinically relevant materials are later received, then the case may be re-opened for further evaluation.Further, it cannot be concluded that the reported clinical reactions were associated with a mal-performance of the implant.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 50MM ID INTL COCR LINER 62MM
• Type of Device: PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house; spa park; leamington spa CV31 3HL; UK CV31 3HL
• MDR Report Key: 10293434
• MDR Text Key: 199447484
• Report Number: 3005477969-2020-00002
• Device Sequence Number: 1
• Product Code: JDH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Type of Report: Initial,Followup
• Report Date: 08/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2018
• Device Catalogue Number: 71335862
• Device Lot Number: 08JW18751
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 71306613 SYN POR FEM COMP SZ 13 09GM12668.; 71331862 R3 0 HOLE ACET SHELL 62MM 08HM07288.; 74222150 BHR MOD HEAD 50MM 09EW23433.; 74222300 MOD SLEEV +4MM 12/14 08LW19889.
• Patient Outcome(s): Other
• Patient Age: 75 YR
• Patient Weight: 86