MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKN R3 CERAMIC LINER; PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL

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

Patient Problems Failure of Implant (1924); Joint Dislocation (2374)

Event Date 01/12/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that a patient had a primary in which a 52 r3 cup with a constrained r3 liner and a 22mm plus 8 ox head were implanted.Patient suffered a dislocation and the locking ring broke.A revision was performed and the r3 liner and the oxinium head were replaced.A new 22mm plus 12 ox head and a new r3 constrained liner were put in.Patient was reduced and stable.

Manufacturer Narrative

The device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, this case reports that a revision surgery of an r3 constrained liner and was performed after the patient experienced a dislocation, in which the locking ring broke.It is unknown how long the device was in situ, or whether a traumatic caused the dislocation.To date, the requested medical records and x-rays have not been provided.Therefore, the patient impact beyond the revision cannot be determined.Due to the lack of information provided, a clinical assessment cannot be rendered.Should additional clinically relevant documentation become available, the clinical/medical task may be re-opened.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Possible causes could include but not limited to traumatic injury, patient anatomy or abnormal loading of limb.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: UNKN R3 CERAMIC LINER
• Type of Device: PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11276146
• MDR Text Key: 230210232
• Report Number: 1020279-2021-00911
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/08/2021

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/12/2021
• Initial Date FDA Received: 02/03/2021
• Supplement Dates Manufacturer Received: 07/08/2021
• Supplement Dates FDA Received: 07/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention