MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG TRIAL FEMORAL HEAD 36 M/+4; PROSTH, HIP, SEMI-CONST, MET/CERAM/POLY, CEMENT OR NON-POROUS, UNCEMENT

Model Number	75100857
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/15/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, after procedure, staff noticed that one of the tabs on the trial head was bent.No surgical delay or injury to the patient was reported.
Additional Manufacturer Narrative
It was reported that, after procedure, staff noticed that one of the tabs on the trial head was bent.The device, intended for use in treatment, was returned for investigation.Upon visual inspection, the reported failure mode could be confirmed.One flap is bent.Apart from that, the device shows signs of use such as dents and scratches on the outer surface.The production documentation was reviewed, there were no deviations found.No additional complaint was detected for the batch in question (a57022).There is no indication that the reported device failed to meet manufacturing specifications upon release for distribution.However, the relationship between the reported event and the device was confirmed.Previous investigations demonstrated that the trial femoral head may disconnect from the stem taper intra-operatively and flaps might bend or 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 could be confirmed, the root cause is attributed to an insufficient design specification.S+n will continue to monitor these devices for similar issues.The returned device will be archived.

• Brand Name: TRIAL FEMORAL HEAD 36 M/+4
• Common Device Name: PROSTH, HIP, SEMI-CONST, MET/CERAM/POLY, CEMENT OR NON-POROUS, UNCEMENT
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• MDR Report Key: 11620378
• Report Number: 9613369-2021-00148
• Device Sequence Number: 3668194
• Product Code: LZO
• UDI-Device Identifier: 07611996121902
• UDI-Public: 07611996121902
• Combination Product (Y/N): N
• 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,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/28/2021

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: 75100857
• Device Catalogue Number: 75100857
• Device Lot Number: UNREADABLE
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/15/2021
• Supplement Date Received by Manufacturer: 05/28/2021
• Initial Report FDA Received Date: 04/06/2021
• Supplement Report FDA Received Date: 05/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1