MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG TRIAL FEMORAL HEAD 36 M/+4; PROST, HIP, SEMI-CNSTRND, MET/CERA/POLY, CMNTD OR NON-POROUS, UNCMNTD

Model Number	75100857
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/13/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal reference number: (b)(4).
Event or Problem Description
It was reported that, during a thr surgery, one trial femoral head 36 m/+4 broke.Surgery was resumed, without any delay, with a smith and nephew back-up device.No health consequences were reported.
Additional Manufacturer Narrative
It was reported that, during a thr surgery, one trial femoral head 36 m/+4 broke.Surgery was resumed, without any delay, with a smith and nephew back-up device.The device intended for use in treatment was not returned for investigation.An evaluation of the complained device could therefore not be conducted, and the reported failure mode could not independently be confirmed.The batch number of this device was not communicated and a review of the batch record could not be conducted.A complaint history review was performed.Based on available information, the reported failure mode could not be confirmed.A relationship between the reported event and the device cannot be confirmed.Based on the available information it is not possible to investigate whether the reported device met manufacturing specifications upon release for distribution.Due to insufficient information it is not possible to speculate about factors which could have contributed to the reported event.No probable cause can be determined.The need for corrective action is not indicated.Nevertheless, smith + nephew will continue to monitor this device for similar issues.This complaint will be reopened should additional information or the device be received.
Additional Manufacturer Narrative
Case-(b)(4).
Additional Manufacturer Narrative
H3, h6: it was reported that, during a thr surgery, one trial femoral head 36 m/+4 broke.Surgery was resumed, without any delay, with a smith and nephew back-up device.The device used in treatment was returned for investigation.The reported issue could be confirmed upon visual inspection.One additional complaint was reported for the batch in question in question.However with a batch size of 267 parts, this does not indicate a batch related issue.A review of the batch record revealed no deviations from the standard manufacturing process that could have contributed to the reported issue.The relationship between the reported event and the device was confirmed.There is no indication that the reported device failed to meet manufacturing specifications upon release for distribution.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 post market surveillance review processes.The reported failure mode of a flap breakage can be confirmed, the root cause is attributed to a insufficient design specification.S+n will continue to monitor these devices for similar issues.The returned device will be discarded.

• Brand Name: TRIAL FEMORAL HEAD 36 M/+4
• Common Device Name: PROST, HIP, SEMI-CNSTRND, MET/CERA/POLY, CMNTD OR NON-POROUS, UNCMNTD
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• Manufacturer (Section G): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 12544924
• Report Number: 9613369-2021-00376
• Device Sequence Number: 1113915
• Product Code: LZO
• UDI-Device Identifier: 07611996121902
• UDI-Public: 07611996121902
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K132435
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/09/2021

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: 75100857
• Device Catalogue Number: 75100857
• Device Lot Number: A57022
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 09/13/2021
• Supplement Date Received by Manufacturer: 10/07/2021; 10/07/2021; 11/09/2021
• Initial Report FDA Received Date: 09/28/2021
• Supplement Report FDA Received Date: 10/08/2021; 11/07/2021; 11/09/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/20/2015
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown