MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG TRIAL FEMORAL HEAD 36 XS/-3; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER

Model Number	75100855
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/05/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during procedure the femoral head trial was found chipped, scraped, and the surgeon made a comment on it.Nothing fell into patient, no delay to procedure, no harm to patient, all pieces recovered.S+n backup device as available.
Additional Manufacturer Narrative
It was reported that during procedure the femoral head trial was found chipped and scraped and the surgeon made a comment on it.The device, intended for use in treatment, was returned for investigation.Upon visual inspection, signs of use such as scratch marks on the entire outside of the trial ball head have been found.Nevertheless, all flaps at the inside of the trial head were intact.Potentially, these scratch marks origin from a grasping forceps.The batch record review did not reveal any irregularities within the manufacturing process and a complaint history review detected only one additional complaints for the batch in question with a similar reported failure mode.Based on the executed investigation steps, the root cause is a component failure probably due to wear and tear.Smith+nephew recommends that all reusable instruments should be routinely inspected for wear and damage and replaced as necessary.The need for corrective action is not indicated.Smith and nephew will continue to monitor this device for similar issues.The returned device will be discarded.

• Brand Name: TRIAL FEMORAL HEAD 36 XS/-3
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• MDR Report Key: 10497035
• Report Number: 9613369-2020-00167
• Device Sequence Number: 2390930
• Product Code: LZO
• UDI-Device Identifier: 07611996121889
• UDI-Public: 07611996121889
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/05/2020

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 Model Number: 75100855
• Device Catalogue Number: 75100855
• Device Lot Number: A52714
• Initial Date Received by Manufacturer: 08/06/2020
• Supplement Date Received by Manufacturer: 09/30/2020
• Initial Report FDA Received Date: 09/04/2020
• Supplement Report FDA Received Date: 10/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1