MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REF THREE HOLE SHELL 52MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

Catalog Number	71336452
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/26/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the liner cannot match with the acetabular cup.Backup device was used.No injury reported.Delay greater than 30 min reported.
Additional Manufacturer Narrative
It was reported that the liner cannot match with the acetabular cup.The associated reflection 3 hole shell was returned and evaluated.A dimensional evaluation was completed on the returned device for all critical-to-quality features, and the failure mode could not be confirmed through this evaluation.No obvious signs of damage was visually observed.Our investigation including a review of the manufacturing records for the listed batch did not reveal any deviation from the standard manufacturing processes.A review of the complaint history for the listed part revealed no prior complaints for the listed failure mode with the same batch number.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A relationship, if any, between the device and the reported incident could not be corroborated.No further investigation warranted for this complaint; however smith and nephew will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.

• Brand Name: REF THREE HOLE SHELL 52MM
• 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: 8883002
• Report Number: 1020279-2019-03010
• Device Sequence Number: 2716069
• Product Code: MBL
• UDI-Device Identifier: 03596010454355
• UDI-Public: 03596010454355
• 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: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/07/2019

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 Catalogue Number: 71336452
• Device Lot Number: 18GM05117
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/26/2019
• Supplement Date Received by Manufacturer: 11/01/2019
• Initial Report FDA Received Date: 08/12/2019
• Supplement Report FDA Received Date: 11/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1