MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REF THREE HOLE SHELL 54MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

Catalog Number	71336454
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Injury (2348)
Date of Event	02/02/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a delay greater than 120 minutes during a thr due to locking inconvenient of the implant.
Additional Manufacturer Narrative
The affected reflection 3 hole shell was returned and evaluated.A lab analysis through a macroscopic examination of the implant, revealed minor scuffs and residue on the inner polished surface near the rim likely from attempted liner insertion and biological fluids.No significant damage was observed on the porous surface.No material or manufacturing deviations were observed in the course of this investigation.A dimensional analysis was also conducted which indicated the product was found to be within the specified print tolerance.A clinical evaluation noted based on the very limited information, a root cause for the liner ¿not fitting¿ cannot be concluded.A review of complaint history on the listed part revealed no additional complaints for this failure mode.A review of the manufacturing records for the listed batch did not reveal any deviation from the standard manufacturing processes.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.Should additional information be received, the complaint will be reopened.

• Brand Name: REF THREE HOLE SHELL 54MM
• 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: 7281560
• Report Number: 1020279-2018-00209
• Device Sequence Number: 19086393
• 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): 05/28/2018

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: 71336454
• Device Lot Number: 17CM19565
• Initial Date Received by Manufacturer: 02/11/2018
• Supplement Date Received by Manufacturer: 02/11/2018; 02/11/2018
• Initial Report FDA Received Date: 02/20/2018
• Supplement Report FDA Received Date: 02/22/2018; 05/28/2018
• 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: Hospitalization
• Patient Age: 54 YR
• Patient Weight: 70