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

Model Number	75100850
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/14/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that after a thr procedure, the plastic tabs of the trial femoral head 32 s/+0 had broken off.No injuries or surgical delays were reported.
Additional Manufacturer Narrative
A trial femoral head 32 s/+0 (art.No.75100850, unknown lot) was reported due to broken tabs after a thr procedure.No injuries or surgical delays were reported.The complaint part, used treatment, was not returned for investigation, however on the provided picture it is seen that one flap was broken and the reported failure mode could be confirmed.Previous investigations demonstrated that the trial femoral head may disconnect from the stem taper intra-operatively and flaps might 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 pms review processes.The reported failure mode of a flap breakage can be confirmed, the root cause is attributed to an insufficient design specification.S+n will continue to monitor these devices for similar issues.
Additional Manufacturer Narrative
A trial femoral head 32 s/+0 (art.No.75100850, unknown lot) was reported due to broken tabs after a thr procedure.No injuries or surgical delays were reported.The complaint part, used treatment, was not returned for investigation, however on the provided picture it is seen that one flap was broken and the reported failure mode could be confirmed.Previous investigations demonstrated that the trial femoral head may disconnect from the stem taper intra-operatively and flaps might 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 pms review processes.The reported faillure mode of a flap breakage can be confirmed, the root cause is attributed to an insufficient design specification.S+n will continue to monitor these devices for similar issues.
Additional Manufacturer Narrative
H3, h6: a trial femoral head 32 s/+0 (art.No.75100850, lot no.A56088) was reported due to broken tabs after a thr procedure.No injuries or surgical delays were reported.The complaint part, used treatment, was returned for investigation.The reported issue could be confirmed upon visual inspection, one of the flap was broken and is missing.The production documentation was reviewed, no deviations from the standard manufacturing procedure were found.The complaint history review was performed, one further complaint of the same lot was found however the root cause of this previous complaint could not be determined since the complaint device was not returned.Previous investigations demonstrated that the trial femoral head may disconnect from the stem taper intra-operatively and flaps might 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 pms review processes.The reported failure mode of a flap breakage can be confirmed, the root cause is attributed to an insufficient design specification.S+n will continue to monitor these devices for similar issues.(b)(4).

• Brand Name: TRIAL FEMORAL HEAD 32 S/+0
• 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: 10523107
• Report Number: 9613369-2020-00172
• Device Sequence Number: 3222322
• Product Code: LZO
• UDI-Device Identifier: 07611996121834
• UDI-Public: 07611996121834
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,Followup,Followup
• Report Date (Section B): 04/07/2021

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: A56088
• Initial Date Received by Manufacturer: 08/17/2020
• Supplement Date Received by Manufacturer: 11/25/2020; 11/25/2020; 03/31/2021
• Initial Report FDA Received Date: 09/11/2020
• Supplement Report FDA Received Date: 12/03/2020; 12/06/2020; 04/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1