MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US 12/14 ARTICUL 44MM M SPEC+8.5; ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS

Model Number	1365-63-000
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Joint Dislocation (2374); Unspecified Tissue Injury (4559)
Date of Event	09/30/2010
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Initial reporter occupation: lawyer.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
Doi: (b)(6) 2008: patient received a right total revision of an unknown primary tha to treat a periprosthetic femoral fracture, dislocation, and pain secondary to a fall.The patient received pinnacle/solution mom tha with two acetabular dome screws and three synthes cables to secure the femoral fracture.The procedure was completed without complications.Dor: (b)(6) 2010: patient received a right hip revision to treat recurrent dislocations.Upon entering the joint, the surgeon identified significant lateral and posterior acetabular wall deficiencies.The cup was well-fixed and stable and retained.The surgeon notes the cup was in 45 degrees of abduction and perhaps 10 degrees anteversion.The dome screws were removed and replaced with longer competitor screws to accommodate the new liner.The depuy metal liner was replaced with a competitor constrained liner that was cemented into place with competitor cement.The head was replaced with a depuy head with a longer neck.The stem was in 10 degrees anteversion, well-fixed, stable, and retained.The procedure was completed without complications.Doi: (b)(6) 2008.Dor: (b)(6) 2010 (head and liner) right 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 (mre) will not be performed since mom systems are obsolete.

• Brand Name: 12/14 ARTICUL 44MM M SPEC+8.5
• Common Device Name: ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY INT'L LTD. 8010379; st. anthony's rd; leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 13823995
• Report Number: 1818910-2022-04925
• Device Sequence Number: 2085561
• Product Code: JDI
• UDI-Device Identifier: 10603295034117
• UDI-Public: 10603295034117
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K060031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2010
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2022

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 Expiration Date: 10/30/2013
• Device Model Number: 1365-63-000
• Device Catalogue Number: 136563000
• Device Lot Number: 2751408
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2022
• Supplement Date Received by Manufacturer: 03/29/2022
• Initial Report FDA Received Date: 03/19/2022
• Supplement Report FDA Received Date: 03/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/08/2008
• 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: CERCL-CABLE W/CRIMP Ø1.7 SST; CERCL-CABLE W/CRIMP Ø1.7 SST; CERCL-CABLE W/CRIMP Ø1.7 SST; PINN CAN BONE SCREW 6.5MMX20MM; PINN CAN BONE SCREW 6.5MMX20MM; PINN MULTIHOLE W/GRIPTION 64MM; PINNACLE MTL INS NEUT44IDX64OD; SOL SYS 8/15.0 R LRG STAT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 58 YR
• Patient Sex: Male