MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG TRIAL FEMORAL HEAD 28 S/+0; PROSTHESIS, HIP, SEMI-CONSTRAIND, MET/CERAM/POLY, CEMNTD OR NON-POROUS, UNCEMENT

Model Number	75100844
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/29/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reference: case-(b)(4).Investigation results: it was reported that during an efip inspection, the trial femoral head 28 s/+0 was found with an unspecified failure.The device, intended for use in treatment, was returned for investigation.Upon visual inspection, it was detected that a flap of the device is broken, so the reported failure mode can be more specified.Previous investigations demonstrated that the trial femoral head may disconnect from the stem taper intra-operatively and flaps might break off.In combination with our continuous effort to improve our products, evaluations aimed at optimizing this instrument have been initiated.The performance of the device is nonetheless within the risks, which are anticipated in the risk management documentation of the product, both in occurrence and severity.The continued performance of the device shall be monitored through standard post market surveillance review processes.The reported failure mode of a flap breakage can be confirmed, the root cause is attributed to a insufficient design specification.S+n will continue to monitor these devices for similar issues.
Event or Problem Description
It was reported that during a efip inspection, the trial femoral head 28 s/+0 was found with a flap broken.

• Brand Name: TRIAL FEMORAL HEAD 28 S/+0
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAIND, MET/CERAM/POLY, CEMNTD OR NON-POROUS, UNCEMENT
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• MDR Report Key: 11429684
• Report Number: 9613369-2021-00100
• Device Sequence Number: 4092101
• Product Code: LZO
• UDI-Device Identifier: 07611996121773
• UDI-Public: 07611996121773
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K132435
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/07/2021

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: 75100844
• Device Catalogue Number: 75100844
• Device Lot Number: A57500
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/01/2021
• Initial Report FDA Received Date: 03/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1