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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/19/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that multihole cup was implanted, and the polys was unable to seat in the shell.Dr checked that the screws were not impeding seating, the shell was removed and replaced with redapt shell.Delay greater than 30 min.
Additional Manufacturer Narrative
It was reported that multihole cup was implanted, and the polys were unable to seat in the shell.Dr checked that the screws were not impeding seating.The shell was removed and replaced with redapt shell.The associated r3 multiple hole acetabular shell and two r3 acetabular liners, used in treatment, were returned and evaluated.A visual inspection of the products found the shell shows some bone cement still attached on the outer diameter of the device.Both liners show no obvious signs of damage.Dimensional inspection was performed on all critical locking features for the liners and shell.Both liners were within tolerance for locking features.However, deviations were observed on different features of the shell.The device failed to meet specifications.A relationship, if any, between the device and the reported incident is corroborated.Therefore, based on the quality investigation, corrective actions have been implemented to help eliminate this issue from recurrence.The root cause of the reported event was the manufacturing operator error.No medical documents were received for investigation.Therefore no medical assessment can be performed at this time.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.
Additional Manufacturer Narrative
The associated r3 multiple hole acetabular shell and two r3 acetabular liners were returned and evaluated.A visual inspection of the products found the shell shows some bone cement still attached on the outer diameter of the device.Both liners show no obvious signs of damage.Dimensional inspection was performed on all critical locking features for the liners and shell.Both liners were within tolerance for locking features.However, deviations were observed on different features of the shell.Therefore, a quality hold has been placed in an attempt to quarantine and re-inspect additional product for this failure mode.Corrective actions have been implemented to help eliminate this issue from recurrence.No further actions are being taken at this time.We consider this investigation closed.Should additional information be received, the complaint will be reopened.
Additional Manufacturer Narrative
Corrected data: b1, h1.Additional information: the event is been re-evaluated for mdr reporting.The information available states that the multihole shell was removed and replaced with a redapt shell, this is considered a medical intervention, therefore, it was determined that this case is reportable as a serious injury and not as a malfunction.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly and a further report submitted outlining both the event details and our investigations performed.

• 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
• MDR Report Key: 8125193
• Report Number: 1020279-2018-02657
• Device Sequence Number: 16735312
• Product Code: MBL
• UDI-Device Identifier: 00885556021804
• UDI-Public: 00885556021804
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 12/06/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 71338666
• Device Catalogue Number: 71338666
• Device Lot Number: 18HM03834
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2018
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/19/2018
• Supplement Date Received by Manufacturer: 07/10/2019; 07/10/2019; 07/10/2019; 12/05/2021; 12/05/2021; 12/06/2021
• Initial Report FDA Received Date: 12/03/2018
• Supplement Report FDA Received Date: 07/13/2019; 03/11/2020; 06/07/2020; 12/05/2021; 12/06/2021; 12/06/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/06/2018
• 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: 71332754/18BM06811; 71332754/18EM15128; 71332754/(B)(4); 71332754/(B)(4)
• Patient Sex: Unknown