MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG TRIAL FEMORAL HEAD 28 S/+0; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Model Number	75100844
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a trial femoral head 28 s/+0 has a crack on top of the head trial.No patient involved.
Additional Manufacturer Narrative
H6: it was reported that a trial femoral head 28 s/+0 has a crack on top of the head trial.No patient involved.The device, intended for use in treatment, was returned for investigation.The relationship between the reported event and the device could be confirmed upon visual inspection.One of the cleaning holes was heavily damaged, potentially originating from a grasping forceps.Apart from that, the device shows normal signs of use such as small dents and scratches on the outer surface.The connection mechanism of the trial head to the stem cone was checked within a functional evaluation which was passed.A complaint history review was performed.One additional complaint with batch a70597 was reported, but with a different reported failure mode as the present complaint issue.A review of the production documentation did not detect any deviation that could have contributed to the reported failure mode.Hence, there is no indication that the reported device failed to meet manufacturing specifications upon release for distribution.Based on the performed investigations, the probable cause for the damaged device is attributed to a wear and tear issue through repeated use over time.According to document "processing (cleaning, disinfection and sterilization) of instruments from smith & nephew orthopaedics ag" (lit.N°03389-en 1363 v3 11/19), all devices must be inspected and controlled for proper functioning after cleaning/disinfection.To date, no further actions are deemed necessary.Smith and nephew will continue to monitor the device for similar issues.Should additional information become available, this complaint will be reassessed.The returned device will be discarded.

• Brand Name: TRIAL FEMORAL HEAD 28 S/+0
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• MDR Report Key: 12203036
• Report Number: 9613369-2021-00322
• Device Sequence Number: 14574384
• Product Code: LZO
• UDI-Device Identifier: 07611996121773
• UDI-Public: 07611996121773
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/08/2021

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2021
• Initial Date Received by Manufacturer: 07/09/2021
• Supplement Date Received by Manufacturer: 08/06/2021
• Initial Report FDA Received Date: 07/21/2021
• Supplement Report FDA Received Date: 08/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1