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

Catalog Number 71928111

Device Problem Break (1069)

Patient Problem Injury (2348)

Event Date 06/02/2020

Event Type  Injury  

Event Description

It was reported that a patient had undergone a thr and had a reflection ceramic/ceramic bearing inserted.The patient had just served the surgeon/rooms with legal papers with intention to sue his/her primary surgery dr.And s+n.The surgeon was unsure about what the patient was doing or what it was in relation to.Upon further investigation by the surgeon he found out the patient had seen another surgeon and had a revision acetabular procedure in 2017.This procedure was performed due to the ceramic liner fractured and the head had pushed though the liner and shell.No implant details currently available.

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, no medical records or documents have been received on this legal complaint.The information will come through the legal department.When the medical/clinical information is received the complaint will be re-opened as assessed at that time.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A complaint history review found related failures for the listed batch; this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Some potential probable causes for this event could include but not limited to traumatic injury or surgical technique.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: 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: 10199239
• MDR Text Key: 196571886
• Report Number: 1020279-2020-02762
• Device Sequence Number: 1
• Product Code: JDH
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 71928111
• Device Lot Number: 05LM06971B
• Date Manufacturer Received: 08/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ANTHOLOGY HO POR PL HA SZ 8; ANTHOLOGY HO POR PL HA SZ 8; FEMORAL HEAD IMPL; R3 SHELL; ANTHOLOGY HO POR PL HA SZ 8; ANTHOLOGY HO POR PL HA SZ 8; FEMORAL HEAD IMPL; R3 SHELL
• Patient Outcome(s): Hospitalization; Required Intervention