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

Model Number	75100850
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/18/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during procedure it was found that the locking tab snapped off.The fragment was found.Surgery was not delayed.
Additional Manufacturer Narrative
It was reported that during procedure it was found that the locking tab snapped off.No injuries or surgical delays reported.The device, used in treatment, was not returned for investigation.A functional evaluation of the product could therefore not be performed.However, a picture of the broken device was provided.Based on this picture, it is clearly visible, that one of the flaps broke.The flap breakage of this device is a known problem.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 this device for similar issues.The complaint will be reopened, should the device be returned or should further information arrive.

• 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, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10407722
• Report Number: 1020279-2020-03920
• Device Sequence Number: 2476566
• Product Code: LZO
• UDI-Device Identifier: 07611996121834
• UDI-Public: 07611996121834
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 75100850
• Device Catalogue Number: 75100850
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/20/2020
• Supplement Date Received by Manufacturer: 10/01/2020
• Initial Report FDA Received Date: 08/14/2020
• Supplement Report FDA Received Date: 10/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention