MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG TRIAL FEMORAL HEAD 32 S/+0; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Model Number	75100850
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
It was reported that, the listed devices were cracked or broken.As this was noticed upon field inspection, there was not patient involvement.
Additional Manufacturer Narrative
It was reported that, the listed devices were cracked or broken.As this was noticed upon field inspection, there was not patient involvement.The device trial femoral head 32 s/+0, intended for use in treatment, was not returned for investigation, but batch number was communicated.A product evaluation could therefore not be performed.Without the return of the device, the relationship between the reported event and the device cannot be confirmed.A review of the production documentation did not reveal any deviation from the standard operating procedure.No additional complaint for the batch in scope was reported so far.There is no indication that the reported device failed to meet manufacturing specifications upon release for distribution.Normal wear and tear through repeated use is known to contribute to the reported event.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.Smith and nephew will continue to monitor the device for similar issues.Apart from that, no further actions are deemed necessary at the time.This investigation is considered closed.The complaint will be reopened should the device be received.

• Brand Name: TRIAL FEMORAL HEAD 32 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: 12488030
• Report Number: 9613369-2021-00364
• Device Sequence Number: 11610946
• Product Code: LZO
• UDI-Device Identifier: 07611996121834
• UDI-Public: 07611996121834
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 10/12/2021

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: 75100850
• Device Catalogue Number: 75100850
• Device Lot Number: A56000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/27/2021
• Supplement Date Received by Manufacturer: 10/11/2021
• Initial Report FDA Received Date: 09/17/2021
• Supplement Report FDA Received Date: 10/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1