MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ANTHOLOGY HO POR PL HA SZ 9; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	71357109
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	07/02/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient had a femoral fracture requiring wiring treatment.
Additional Manufacturer Narrative
Additional information: device identification, device manufacture date.The associated complaint device was not returned.A clinical evaluation was conducted and without the requested clinical information a thorough medical investigation cannot be rendered.Should any additional clinical information be provided this complaint will be re-evaluated.A review of complaint history on the listed part revealed no prior complaints for the listed batch with the same failure mode.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.
Event or Problem Description
It was reported that the patient had a femoral fracture requiring wiring treatment.The patient recovered from the adverse event and was discharged the (b)(6) 2019.
Additional Manufacturer Narrative
The device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The medical investigation concluded that this complaint is from japan, the hope study.It was reported that the patient had a femoral fracture requiring wiring treatment.The patient recovered from the adverse event and was discharged the (b)(6) 2019.Only study forms were submitted for review.No clinical/medical documents were provided for the investigation.Without supporting clinical/medical documents, a thorough investigation cannot be performed.Should information become available this complaint can be re-assessed.A review of complaint history did not reveal additional complaints for the listed batch.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.Some potential probable causes of this event could include improper surgical technique or poor bone quality.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device or additional information be received, the complaint will be reopened.No further investigation warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.

• Brand Name: ANTHOLOGY HO POR PL HA SZ 9
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8867909
• Report Number: 1020279-2019-02951
• Device Sequence Number: 11479024
• Product Code: JDI
• UDI-Device Identifier: 03596010559647
• UDI-Public: 03596010559647
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K052792
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,s
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/19/2020

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/27/2025
• Device Model Number: 71357109
• Device Catalogue Number: 71357109
• Device Lot Number: 15FM22828
• Initial Date Received by Manufacturer: 07/12/2019
• Supplement Date Received by Manufacturer: 12/06/2019; 01/20/2020; 01/20/2020
• Initial Report FDA Received Date: 08/07/2019
• Supplement Report FDA Received Date: 12/12/2019; 01/22/2020; 03/19/2020
• 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: Congenital Anomaly; Hospitalization
• Patient Age: 74 YR