MAUDE Adverse Event Report: SMITH & NEPHEW, INC. INTL ALUM CER 28MM HD 12/14 +4; PROSTH, HIP, SEMI-CONST, MET/CERAM/POLY, CEMENT OR NON-POROUS, UNCEMENT

Model Number	71332804
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/24/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a hemiarthroplasty surgery, with polarstew uncemented femoral stem, tandem lntl bipolar head used, the head broke while implanting.S&n backup device available.No more information provided yet.
Additional Manufacturer Narrative
It was reported that during a hemiarthroplasty surgery with polarstew uncemented femoral stem, the head broke while implanting.The affected tandem ceramic head, used in treatment, was returned and evaluated.A lab analysis conducted during this investigation noted that visual inspection showed the femoral head fractured into multiple fragments.Visual analysis of the female taper bore surfaces of the head fragments showed metal transfer, and indicated the most likely fracture initiation site was near the gage point region.Additional cracks near the apex were observed as well.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.Some potential causes of the reported event could include but are not limited to procedural/user error, improper size of device used or material in use.Based on this investigation, the need for corrective action is not indicated.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.

• Brand Name: INTL ALUM CER 28MM HD 12/14 +4
• Common Device Name: PROSTH, HIP, SEMI-CONST, MET/CERAM/POLY, CEMENT OR NON-POROUS, UNCEMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8815966
• Report Number: 1020279-2019-02721
• Device Sequence Number: 343366
• Product Code: LZO
• UDI-Device Identifier: 03596010385345
• UDI-Public: 03596010385345
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K981847
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2020

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 Expiration Date: 07/18/2026
• Device Model Number: 71332804
• Device Catalogue Number: 71332804
• Device Lot Number: 16GT73098
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/25/2019
• Supplement Date Received by Manufacturer: 05/19/2020
• Initial Report FDA Received Date: 07/23/2019
• Supplement Report FDA Received Date: 05/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 85 YR
• Patient Weight: 59