MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ARTICULEZE M HEAD 36MM -2; ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS

Model Number 1365-50-000

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Joint Laxity (4526); Physical Asymmetry (4573)

Event Date 01/27/2005

Event Type  Injury  

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 Description

Pinnacle mom medical records received.After review of the medical records the patient was revised to address instability, subluxation, clunking of the hip.Operative note reported the hip was subluxing anteriorly.There was some excessive longitudinal instability of the hip, serous drainage was encountered in the hip joint and some excessive anteversion.Shortening was performed resulted to some anterior instability.Doi: (b)(6) 2005;dor: (b)(6), 2005; left hip.

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 136550000, lot 1193201 and no non-conformances / manufacturing irregularities related to the malfunction were identified.H10 additional narrative: added: e3 initial reporter occupation: lawyer.

• Brand Name: ARTICULEZE M HEAD 36MM -2
• Type of Device: 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: 13769753
• MDR Text Key: 289002793
• Report Number: 1818910-2022-04686
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 10603295033899
• UDI-Public: 10603295033899
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K980513
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 03/15/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2009
• Device Model Number: 1365-50-000
• Device Catalogue Number: 136550000
• Device Lot Number: 1193201
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/15/2022
• Supplement Dates Manufacturer Received: 04/01/2022
• Supplement Dates FDA Received: 04/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/28/2004
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: PINN CAN BONE SCREW 6.5MMX30MM; PINNACLE MTL INS NEUT36IDX56OD; PINNACLE SECTOR II CUP 56MM; SUMMIT POR TAPER SZ7 STD OFF
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male