MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REF THREE HOLE SHELL 50MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

Model Number	71336450
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/12/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery, hole cover passed completely through the acetabular shell and could not be retrieved as shell was already screwed into place.No injury and a delay of less than 30 minutes was reported.It is unknown how the procedure was concluded.
Additional Manufacturer Narrative
H10: the device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.A review of the device history record 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 the complaint history for the listed part revealed no prior complaints for the listed failure mode with this same batch number.Factors and/or potential probable causes that could have contributed to the reported event include but are not limited to surgical technique, procedural/user error, design of device.H6: device code was corrected.

• Brand Name: REF THREE HOLE SHELL 50MM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9426262
• Report Number: 1020279-2019-04308
• Device Sequence Number: 469992
• Product Code: MBL
• UDI-Device Identifier: 03596010454348
• UDI-Public: 03596010454348
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K960094
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/28/2020

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: 71336450
• Device Catalogue Number: 71336450
• Device Lot Number: 19JM19154
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/12/2019
• Supplement Date Received by Manufacturer: 05/27/2020
• Initial Report FDA Received Date: 12/06/2019
• Supplement Report FDA Received Date: 05/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1