MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US AML LG STATURE 13.5MM; AML IMPLANT : HIP FEMORAL STEM

Model Number	1554-02-135
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/23/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that the 13.5 large aml stem broke in a transverse plane 120.31mm distally from the implant shoulder.40+12 ts head was implanted 1 day prior ((b)(6) 2021) in a head and liner exchange (previously mom).The head was not damaged not re-inserted only due to surgeons decision to downsize.There was no surgical delay.Doi: unknown, dor: (b)(6) 2021, affected side: left hip.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot: a manufacturing record evaluation was performed for the finished device 155402135, lot dx7h31000, and no non-conformance's / manufacturing irregularities were identified.

• Brand Name: AML LG STATURE 13.5MM
• Common Device Name: AML IMPLANT : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 13224491
• Report Number: 1818910-2022-00545
• Device Sequence Number: 19874848
• Product Code: LPH
• UDI-Device Identifier: 10603295058366
• UDI-Public: 10603295058366
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K012364
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/11/2022

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: 1554-02-135
• Device Catalogue Number: 155402135
• Device Lot Number: DX7H31000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/23/2021
• Supplement Date Received by Manufacturer: 02/14/2022
• Initial Report FDA Received Date: 01/11/2022
• Supplement Report FDA Received Date: 02/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/17/2009
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AML LG STATURE 13.5MM; CREATED IN ERROR; DLT TS CER HD 12/14 40MM +12
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male