MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REF THREE HOLE SHELL 60MM; PROSTHESIS,HIP,SEMI-CONSTRAINED,UNCEMENTED,METAL/POLYMER,POROUS

Model Number	71336460
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/04/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery, cup and corresponding liner did not fit properly.It is unknown how the procedure was concluded or if there was a delay.No injury reported.
Additional Manufacturer Narrative
Additional information:event.
Event or Problem Description
It was reported that during surgery, cup and corresponding liner did not fit properly.Procedure was postponed since a backup device was not available.
Additional Manufacturer Narrative
The associated complaint devices were not returned.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incidents.A review of complaint history on the listed part revealed no prior complaints for the listed batch with the same failure mode.Without the actual products involved and/or device information, our investigation cannot proceed.If the devices or new information is received in the future, these complaints can be re-opened.No further actions are being taken at this time.
Additional Manufacturer Narrative
The associated devices, used in treatment, were returned and evaluated.A visual inspection of the returned devices could not confirm the stated failure mode.The devices have some signs of damage from implantation / insertion / extraction.The devices were manufactured in 2018 and 2019.A dimensional inspection of the shell found it to be within specification.A review of complaint history did not reveal additional complaints for the listed batches.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Some potential probable causes of the reported event could include improper insertion technique or device damaged during insertion.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.

• Brand Name: REF THREE HOLE SHELL 60MM
• 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: 9142172
• Report Number: 1020279-2019-03526
• Device Sequence Number: 14205189
• Product Code: MBL
• UDI-Device Identifier: 03596010454393
• UDI-Public: 03596010454393
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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,Followup,Followup
• Report Date (Section B): 03/31/2020

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: 71336460
• Device Catalogue Number: 71336460
• Device Lot Number: 18HM13760
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2020
• Initial Date Received by Manufacturer: 09/04/2019
• Supplement Date Received by Manufacturer: 09/04/2019; 10/31/2019; 10/31/2019
• Initial Report FDA Received Date: 10/01/2019
• Supplement Report FDA Received Date: 10/04/2019; 11/06/2019; 03/31/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PART NUMBER 71332520 / LOT NUMBER 19BM00117; PART NUMBER 71332530 / LOT NUMBER 19CM21303