MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ARTICULEZE M HEAD 36MM +8.5; ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS

Model Number 1365-53-000

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

Patient Problems Pain (1994); Discomfort (2330); Injury (2348); Test Result (2695); No Code Available (3191)

Event Date 01/05/2018

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Initial reporter occupation: lawyer.(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 claim submission form and medical records received.After review of the medical records the patient was revised due to pain, discomfort with elevated metal ions.Operative note reported abundant amount of capsular tissue was excised and some inferior bone.However, there were no lab result provided for the metal ions.Doi: (b)(6) 2006.Dor: (b)(6) 2018; left hip 2nd revision.

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.

• Brand Name: ARTICULEZE M HEAD 36MM +8.5
• 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
• MDR Report Key: 10574035
• MDR Text Key: 208144896
• Report Number: 1818910-2020-20729
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295033950
• UDI-Public: 10603295033950
• Combination Product (y/n): N
• PMA/PMN Number: K980513
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 09/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2011
• Device Model Number: 1365-53-000
• Device Catalogue Number: 136553000
• Device Lot Number: 2203301
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 5.0MM DIA TPRD HD PER SCRW 55; 5.0MM DIA TPRD HD PER SCRW 55; CONTROL CABLE W/CABLE SLEEVE; CONTROL CABLE W/CABLE SLEEVE; CONTROL CABLE W/CABLE SLEEVE; CONTROL CABLE W/CABLE SLEEVE; PINNACLE DP REV ACET CUP 62MM; PINNACLE MTL INS NEUT36IDX56OD; SOL 21.0 BOW LT 8.0 12/14; 5.0MM DIA TPRD HD PER SCRW 55; 5.0MM DIA TPRD HD PER SCRW 55; CONTROL CABLE W/CABLE SLEEVE; CONTROL CABLE W/CABLE SLEEVE; CONTROL CABLE W/CABLE SLEEVE; CONTROL CABLE W/CABLE SLEEVE; PINNACLE DP REV ACET CUP 62MM; PINNACLE MTL INS NEUT36IDX56OD; SOL 21.0 BOW LT 8.0 12/14
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Weight: 120