MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ACTIS COLLARED HIGH SIZE 10; HIP FEMORAL STEM

Model Number	1010-12-100
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Limb Fracture (4518)
Date of Event	01/15/2019
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
On (b)(6) 2019 patient had left hip pain in hip and loud noise.On (b)(6) 2019 patient had femur fracture and broken steel plate (synthes).Then the patient was revised on (b)(6) 2019.Patient had undergone a total hip arthroplasty revision and open reduction internal fixation due to failure orif left tha peri-prosthetic fracture(no infection noted).They had managed to support the fracture with synthes trauma devices and replaced only the stem with a competitor(stryker).Doi: (b)(6) 2019: dor: (b)(6) 2019; left hip 2nd complaint.
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 the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• Brand Name: ACTIS COLLARED HIGH SIZE 10
• Common Device Name: HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 15637902
• Report Number: 1818910-2022-20925
• Device Sequence Number: 6376744
• Product Code: MEH
• UDI-Device Identifier: 10603295380627
• UDI-Public: 10603295380627
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K150862
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Consumer,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/20/2022

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: 1010-12-100
• Device Catalogue Number: 101012100
• Device Lot Number: J17W46
• 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: 10/04/2022
• Supplement Date Received by Manufacturer: 12/01/2022
• Initial Report FDA Received Date: 10/20/2022
• Supplement Report FDA Received Date: 12/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/16/2019
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ACTIS COLLARED HIGH SIZE 10; ALTRX NEUT 36IDX58OD; APEX HOLE ELIM; BONE SCREW 6.5MMX45MM; DELTA CER HEAD 12/14 36MM +5; PINN CUP 58MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male