MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD R3 40MM ID US COCR LNR 52MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 71341152

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

Patient Problems Pain (1994); Swelling (2091); Toxicity (2333); Test Result (2695)

Event Date 03/25/2016

Event Type  Injury  

Event Description

It was reported that a right hip revision was performed due to pain, metallosis, lysis, large fluid collection.

Manufacturer Narrative

It was reported that right hip revision surgery was performed.During the revision, the r3 liner, hemi head + modular sleeve were removed.The r3 shell, stem + screws were retained.As of today, the implanted devices, all of which were used in treatment, and additional information has been requested for this complaint but has not become available.Without definitive part/lot numbers a complete complaint history review cannot be performed for the devices involved.A review of the complaint history for the liner/ 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 liner.Similar complaints have been identified for the sleeve and this failure will continue to be monitored.In the absence of the actual devices, the production records were reviewed for the known devices reportedly involved in this incident.Device history record review confirmed that all released parts met specifications applicable 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.The medical documents were reviewed.In conclusion, based on the intraoperative findings of the grey debris, fluid collections and bone and soft tissue loss, may be consistent with a reaction to metal debris.However, the source and the root cause cannot be determined with the available documentation.It is unknown if this patients pre-existing ¿eburnated bone¿ contributed to the issues.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: 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: 9183963
• MDR Text Key: 162372572
• Report Number: 3005975929-2019-00357
• 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,Followup
• Report Date: 06/08/2021

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: 12/29/2018
• Device Catalogue Number: 71341152
• Device Lot Number: 08MW20428
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/25/2019
• Initial Date FDA Received: 10/14/2019
• Supplement Dates Manufacturer Received: 09/25/2019; 05/17/2021
• Supplement Dates FDA Received: 02/07/2020; 06/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: HEMI HEAD 74122540, LOT UNKNOWN; MODULAR SLEEVE -4MM 12/14 74222100/ 08CW16010; OR71309012; OR71332525; OR71332525; OR71332525; OR71335552; OR74122540; OR74222100
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR