MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG TRIAL FEMORAL HEAD 22 XL/+12; PROSTHSS,HIP,SMI-CNSTRND,METAL/CERAMIC/PLYMR,CEMENTED OR NON-POROUS,UNCEMENTED

Model Number	75100842
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/02/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the trial femoral head was found broken in a warehouse.No procedure-related.
Additional Manufacturer Narrative
It was reported that the trial femoral head was found broken in a warehouse.This case is not procedure-related.The device, used in treatment, was not returned for investigation.Furthermore, no batch number was communicated.Therefore, a thorough complaint investigation could not be conducted.Previous investigations demonstrated that the trial femoral head may disconnect from the stem taper intra-operatively and flaps might bend or break off.If the current issue is related to this failures cannot be determined as no product was returned.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 root cause cannot be established based on the available information.S+n will continue to monitor these devices for similar issues.

• Brand Name: TRIAL FEMORAL HEAD 22 XL/+12
• Common Device Name: PROSTHSS,HIP,SMI-CNSTRND,METAL/CERAMIC/PLYMR,CEMENTED OR NON-POROUS,UNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• MDR Report Key: 10446201
• Report Number: 9613369-2020-00161
• Device Sequence Number: 19827153
• Product Code: LZO
• UDI-Device Identifier: 07611996121759
• UDI-Public: 07611996121759
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Report Date (Section B): 10/27/2020

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: 75100842
• Device Catalogue Number: 75100842
• Initial Date Received by Manufacturer: 08/02/2020
• Supplement Date Received by Manufacturer: 10/23/2020
• Initial Report FDA Received Date: 08/24/2020
• Supplement Report FDA Received Date: 10/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1