MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG TRIAL FEMORAL HEAD 28 XXL/+16; PROSTH, HIP, SEMI-CONST, MET/CERAM/POLY, CEMENT OR NON-POROUS, UNCEMENT

Model Number	75100848
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, the trial femoral head 28 xxl/+16 was broken.It was unknown if this occurred during surgery or not; therefore, patient involvement has not been confirmed.
Additional Manufacturer Narrative
H3, h6: it was reported that, the trial femoral head 28 xxl/+16 was broken.To date no batch number was communicated and the part, which intent use is in treatment, was not returned for investigation.Neither a device history record review, nor a batch related complaint history review could be performed.For the specific article number only on additional complaint was recorded which reports a damaged device.It can not be stated that the device failed meeting specification at time of manufacturing.A relationship between the device and the reported event can not be confirmed.The failure mode can not be independently confirmed as well.The root cause can not be established and no potential contributing factor can be identified.No further actions are possible at that time.Should additional information get available in future this complaint will be re-assessed.S+n will monitor this device for similar issues.

• Brand Name: TRIAL FEMORAL HEAD 28 XXL/+16
• Common Device Name: PROSTH, HIP, SEMI-CONST, MET/CERAM/POLY, CEMENT OR NON-POROUS, UNCEMENT
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• MDR Report Key: 12043042
• Report Number: 9613369-2021-00307
• Device Sequence Number: 14453171
• Product Code: LZO
• UDI-Device Identifier: 07611996121810
• UDI-Public: 07611996121810
• Combination Product (Y/N): N
• Initial Reporter State: VT
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/03/2021

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: 75100848
• Device Catalogue Number: 75100848
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/03/2021
• Supplement Date Received by Manufacturer: 07/30/2021
• Initial Report FDA Received Date: 06/22/2021
• Supplement Report FDA Received Date: 08/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1