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	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Information (3190)
Date of Event	10/31/2018
Type of Reportable Event	Malfunction
Event or Problem Description
During right total hip replacement surgery, the screw goes through the acetabular outer cup.
Additional Manufacturer Narrative
The associated reflection 3 hole shell was not returned for evaluation.Our investigation including a review of the manufacturing records for the listed part with the listed batch did not reveal any deviation from the standard manufacturing processes.A review of complaint history for the listed part revealed no prior complaints for the listed failure mode with the same batch number.Our clinical evaluation noted that the x-ray provided confirms the screw through the shell but details on placement or details of the screw were not included.Without additional information we can¿t comment on the stability of the cup or the placement of the screw through the cup as it does have 2 others.In addition, ¿the implantation of the screw under power¿, as a likely contributing factor cannot be ruled out.Since a revision has not been planned, the future impact to the patient beyond the possibility of screw migration cannot be determined.Should additionally clinical information be provided this complaint will be re-assessed.Our investigation indicated this issue has been communicated to the product support group for consideration for further action.Without the return of the actual product involved, our investigation of this report is inconclusive.No further investigation warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should the device or additional information be received, the complaint will be reopened.We consider this investigation closed.

• 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: 8100345
• Report Number: 1020279-2018-02571
• Device Sequence Number: 1947104
• 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: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/09/2019

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: 17JM18572
• Initial Date Received by Manufacturer: 11/01/2018
• Supplement Date Received by Manufacturer: 11/01/2018
• Initial Report FDA Received Date: 11/24/2018
• Supplement Report FDA Received Date: 05/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 84 YR