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	02/26/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during tha, the tabs that hold the head on a trunnion have snapped off while trialing.Sn backup was available.No delay was recorded.
Additional Manufacturer Narrative
It was reported that the tabs of a trial femoral head 36 xs/-3 have snapped off while trialing, a s+n backup was available.No delay was recorded.The complaint device, used in treatment, was not returned for investigation.The product evaluation could hence not confirm the reported failure mode.The complaint history review was performed and no other complaint was reported for devices of the same production lot.No deviations were found from the standard operating procedure in the production documentation review.Based on the conducted investigation, the root cause could not be determined conclusively for this complaint.However, previous investigations demonstrated that the trial femoral head may disconnect from the stem taper intra-operatively.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 pms review processes.The complaint will be reopened should the part will be returned or should additional information be received.S+n will continue to monitor these devices for similar issues.

• 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; oberneuhofstrasse 10d; baar 06340 ; SZ 06340
• MDR Report Key: 9841896
• Report Number: 9613369-2020-00069
• Device Sequence Number: 2856022
• Product Code: LZO
• UDI-Device Identifier: 07611996121889
• UDI-Public: 07611996121889
• 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,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/22/2021

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?: No
• Operator of Device: No Information
• Device Model Number: 75100855
• Device Catalogue Number: 75100855
• Device Lot Number: A57531
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/26/2020
• Supplement Date Received by Manufacturer: 04/24/2020; 03/17/2021
• Initial Report FDA Received Date: 03/17/2020
• Supplement Report FDA Received Date: 04/28/2020; 03/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1