MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 MULTI HOLE ACETABULAR SHELL 52MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

Model Number 71338665

Device Problem Misconnection (1399)

Patient Problem Injury (2348)

Event Date 05/26/2020

Event Type  Injury  

Event Description

It was reported that after surgery the acetabular screw exited the screw hole in the 52mm r3 mulithole cup, this was seen in an x-ray.The surgeon reported the screw was firmly seated at the bottom of the hole with excellent purchase.It appeared to go beyond the cup at the time it was implanted.

Event Description

It was reported that after surgery the acetabular screw exited the screw hole in the 52mm r3 mulithole cup, this was seen in an x-ray.The surgeon reported that both screws were firmly seated at the bottom of the hole with excellent purchase.Neither screw appeared to go beyond the cup at the time they were implanted.

Manufacturer Narrative

H3, h6: the device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, based on the information provided, the root cause of the reported event could not be definitively concluded.The patient impact beyond the reported screw through the shell could not be determined.No further medical assessment can be rendered at this time.Should additional clinical documentation become available in the future, the clinical/medical task may be re-evaluated.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 additional complaints for the listed batch.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.Factors and/or some potential probable causes that could contribute to the reported event have been identified as but not limited to abnormal motion over time, bone degeneration, fit/sizing, lack of ingrowth, lifetime of device, and traumatic injury.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 MULTI HOLE ACETABULAR SHELL 52MM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10183169
• MDR Text Key: 196053358
• Report Number: 1020279-2020-02641
• Device Sequence Number: 1
• Product Code: MBL
• UDI-Device Identifier: 00885556021491
• UDI-Public: 00885556021491
• Combination Product (y/n): N
• PMA/PMN Number: K092386
• 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: 07/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 71338665
• Device Catalogue Number: 71338665
• Device Lot Number: 20CM16369
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention