MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 MULTI HOLE ACETABULAR SHELL 54MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

Model Number	71338666
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/03/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery the implants did not seat.A back device was available and less than 30 minutes delay was reported.
Additional Manufacturer Narrative
The associated devices, used in treatment, were returned and evaluated.A visual inspection of the returned devices could not confirm the stated failure mode.The devices had numerous scratches and nicks from the attempted implantation and extraction.The devices were manufactured in 2018.A dimensional inspection of the shells found the devices did not meet specification.A dimensional inspection of the liners found the devices did meet specification.A review of complaint history did not reveal additional complaints for the listed batches.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we have reason to suspect that the product failed to meet product specifications at the time of manufacture.The potential probable cause for this event is likely a manufacturing process error.Based on this investigation, the need for corrective action is indicated.

• Brand Name: R3 MULTI HOLE ACETABULAR SHELL 54MM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer Contact: sarah freestone ; 1450 brooks road; memphis, TN 38116 ; 0447940038246
• MDR Report Key: 9820980
• Report Number: 1020279-2020-00835
• Device Sequence Number: 16885997
• Product Code: MBL
• UDI-Device Identifier: 00885556021804
• UDI-Public: 00885556021804
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K092386
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 71338666
• Device Catalogue Number: 71338666
• Device Lot Number: 18HM03836
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2019
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/03/2019
• Supplement Date Received by Manufacturer: 04/08/2020; 12/06/2021; 09/27/2022
• Initial Report FDA Received Date: 03/11/2020
• Supplement Report FDA Received Date: 04/14/2020; 12/06/2021; 09/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/08/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-2331-2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 71336954 / 18LM16657
• Patient Sex: Unknown