MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REF THREE HOLE SHELL 54MM; PRSTHSS,HIP,SMCNSTRND,UNCMNTD,MTALPLYMR,PROS

Catalog Number	OR71336454
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/30/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
A delay greater than 2 hours was reported due to connection problems between implants.To correct this situation, the surgeon decided to implant a back up device instead.
Event or Problem Description
A delay of 90 minutes was reported due to connection problems between implants.To correct this situation, the surgeon decided to implant a back up device instead.
Additional Manufacturer Narrative
The associated device was returned and evaluated.No destructive test performed on this retrieved component.Visual inspection of returned reflection size 54 shell did not reveal any physical damage.The size of 54mm verified and visual verification of the markings indicated the correct part number and size.There are no indications of any deviations in material or manufacturing process.A review of manufacturing records did not reveal any deviations that could have contributed to the reported issue.A review of complaint history revealed that we have not had any previous complaints for the listed batch.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.If additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: REF THREE HOLE SHELL 54MM
• Common Device Name: PRSTHSS,HIP,SMCNSTRND,UNCMNTD,MTALPLYMR,PROS
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7244263
• Report Number: 1020279-2018-00124
• Device Sequence Number: 19126122
• Product Code: MBL
• UDI-Device Identifier: 03596010454362
• UDI-Public: 03596010454362
• 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,Followup
• Report Date (Section B): 05/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: OR71336454
• Initial Date Received by Manufacturer: 01/30/2018
• Supplement Date Received by Manufacturer: 01/30/2018; 01/30/2018
• Initial Report FDA Received Date: 02/06/2018
• Supplement Report FDA Received Date: 02/07/2018; 05/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 54 YR
• Patient Weight: 70