MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 UNK BROACH; HIP FEMORAL STEM

Model Number	L20311
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Limb Fracture (4518)
Date of Event	04/19/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (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
Clinical adverse event received for periprosthetic calcar fracture - femoral (intraoperative).Event is serious and is considered mild.Event is possibly related to device and is definitely related to procedure.Date of implantation: (b)(6) 2022.Date of event (onset): (b)(6) 2022.Affected side: (right hip).Treatment: open reduction internal fixation.
Additional Manufacturer Narrative
Product complaint (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information, which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained, that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
Medical records received, indicated that the "primary operative notes 04/19/2022, indicate the patient received a right total hip replacement, due to end stage osteoarthritis.During broaching of the femur, a small femoral fracture occurred.Orif with synthes cables were placed.Surgery was completed without further complication".
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: the device associated with this complaint was not received for examination.The photo investigation found nothing indicative of a device nonconformance.However an unknown fracture repair wire can be seen.The x-rays provided does not represent the device associated with this complaint.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot: a device history record (dhr) review or manufacturing records evaluation (mre) was not possible because the required lot code was not provided.

• Brand Name: UNK BROACH
• Common Device Name: HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• Manufacturer (Section G): DEPUY ORTHOPAEDICS INC 1818910; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 14399687
• Report Number: 1818910-2022-08899
• Device Sequence Number: 5451907
• Product Code: LZO
• UDI-Device Identifier: 10603295258025
• UDI-Public: 10603295258025
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K190344
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/13/2022

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?: No
• Operator of Device: Health Professional
• Device Model Number: L20311
• Device Catalogue Number: UNK BROACH
• Device Lot Number: 5350485
• 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: 04/27/2022
• Supplement Date Received by Manufacturer: 05/04/2022; 06/16/2022
• Initial Report FDA Received Date: 05/13/2022
• Supplement Report FDA Received Date: 05/19/2022; 06/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2019
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR
• Patient Sex: Female
• Patient Weight: 73 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White