MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REF THREE HOLE SHELL 44MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

Catalog Number	71336444
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/29/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent a total hip replacement.During surgery a delay greater than 30 minutes was reported due to the cup didn't fit with the liner, a bigger cup and liner size had to be implanted and fixed with bone cement.Outcome of the patient was good.
Additional Manufacturer Narrative
The associated reflection liner and reflection 3 hole shell were returned and evaluated.Our investigation including a review of the manufacturing records for the listed batches did not reveal any deviation from the standard manufacturing processes.A review of the complaint history for the listed parts revealed no prior complaints for the listed failure mode with the same batch number.A quality hold was requested.With the information currently available, we are considering this to be an isolated event.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.We consider this investigation closed.

• Brand Name: REF THREE HOLE SHELL 44MM
• 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: 8141939
• Report Number: 1020279-2018-02713
• Device Sequence Number: 16191725
• Product Code: MBL
• UDI-Device Identifier: 03596010460523
• UDI-Public: 03596010460523
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K960094
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2019

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 Expiration Date: 12/11/2025
• Device Catalogue Number: 71336444
• Device Lot Number: 15MM09496
• Initial Date Received by Manufacturer: 11/08/2018
• Supplement Date Received by Manufacturer: 11/08/2018
• Initial Report FDA Received Date: 12/07/2018
• Supplement Report FDA Received Date: 04/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1