MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 36MM ID INTL DLT CER LNR 58MM; PROST, HIP, SEMI-CNSTRND, UNCMNTD, MET/POLY, POROUS

Catalog Number 71331758

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

Patient Problem Subluxation (4525)

Event Date 12/10/2021

Event Type  malfunction  

Manufacturer Narrative

Internal reference number: case-(b)(4).

Event Description

It was reported that, after a left thr surgery performed on the (b)(6) 2021 via posterior approach with anthology/r3 conc construct, the patient had dislocated hip at rehab post-op.The patient had a revision left thr surgery on (b)(6) 2021 to treat this adverse event.The components seemed well fixed and in appropriate position by surgeon.The patient was dislocating during flexion and ir during rom test.The biolox delta head 36 mm 12/14 s / +0 was removed with punch and the r3 36mm id intl dlt cer lnr 58mm was removed with a liner removal tool.The patient was trialed with 36mm heads and 36x58/20 degree liner trials and the hip seemed stable in rom.20 degree xlpe liner inserted and impacted into r3 shell, and 36mm l biolox option head impacted to retained anthology stem.The hip was stable through rom.The wound was irrigated and closed in layers.The patient was not harmed beyond the reported problem.

Manufacturer Narrative

The associated device was not returned for evaluation and the reported event could not be confirmed, therefore, the contribution of the device to the reported event could not be corroborated.The clinical/medical investigation concluded that, smith and nephew has not received the device/ 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.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history did not reveal similar events for the listed device.A review of the instructions for use document and the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.An historical review concluded that there are no prior actions related to this product and event.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 are not limited to traumatic injury, alignment or fit size of the device used.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 36MM ID INTL DLT CER LNR 58MM
• Type of Device: PROST, HIP, SEMI-CNSTRND, UNCMNTD, MET/POLY, POROUS
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 13111724
• MDR Text Key: 282918513
• Report Number: 1020279-2021-08952
• Device Sequence Number: 1
• Product Code: MBL
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 71331758
• Device Lot Number: 17GT90111
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/28/2022
• Date Device Manufactured: 07/17/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization