MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 0 HOLE ACET SHELL 52MM; PRSTHSS, HP, SM-CNSTRND, UNCMNTD, MTL/POLYMR, PRS

Model Number	71331852
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	Injury (2348)
Date of Event	12/10/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during surgery cup would not seat.A bigger size cup had to use (s+n back up).Delay under 30 min, and no injury to patient.
Additional Manufacturer Narrative
The device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.A clinical evaluation indicated that it was reported that after trailing with a 52mm acetabular cup, the definite cup ¿would not seat¿ and the surgeon ¿had to use a bigger size cup¿.The root cause of the event could not be determined based on the limited information provided.Per correspondence, the surgeon was ¿happy with outcome¿ and did ¿not anticipate any further patient impact¿; therefore, patient impact beyond the reported minor surgical extension would not be anticipated, although this could not be definitively concluded.Should clinical documentation become available in the future, the clinical/medical task may be re-evaluated.No further medical assessment is warranted at this time.A review of the device history records for the listed batch did not reveal any deviation from the standard manufacturing processes.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of complaint history for the listed parts revealed no prior complaints for the listed failure mode with the same batch numbers.A review of the risk management file and instructions for use document for this failure mode was conducted.Factors and/or potential probable causes that could have contributed to the reported event include but are not limited to wrong size, surgical technique, alignment.Without the return of the actual product involved and no patient medical records, our investigation of this report is inconclusive.Based on this investigation, the need for corrective action is not indicated.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.We consider this investigation closed.

• Brand Name: R3 0 HOLE ACET SHELL 52MM
• Common Device Name: PRSTHSS, HP, SM-CNSTRND, UNCMNTD, MTL/POLYMR, PRS
• 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: 9572220
• Report Number: 1020279-2020-00181
• Device Sequence Number: 2133519
• Product Code: MBL
• UDI-Device Identifier: 03596010597595
• UDI-Public: 03596010597595
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K070756
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/04/2022

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?: No
• Operator of Device: Health Professional
• Device Model Number: 71331852
• Device Catalogue Number: 71331852
• Device Lot Number: 19DW18993
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 12/10/2019
• Supplement Date Received by Manufacturer: 09/30/2020; 10/03/2022
• Initial Report FDA Received Date: 01/09/2020
• Supplement Report FDA Received Date: 10/07/2020; 10/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/25/2019
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown