MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE MTL INS NEUT44IDX66OD; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR LINERS

Catalog Number 121887466

Device Problem Naturally Worn (2988)

Patient Problems Atrial Tachycardia (1731); Foreign Body Reaction (1868); Pain (1994); Test Result (2695); No Code Available (3191)

Event Date 11/14/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial reporter occupation: lawyer.Follow-up being conducted to obtain contact information.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Pinnacle medical records received.After review of medical records patient was revised to addressed pain, elevated metal ion levels.Operative notes indicated evidence of trunnionosis with black metal debris at the trunnion.During operation anesthesia informed that the patient was not doing well in fact went into severe bradycardia and hypoxia and an emergent code was called at which point they sealed the wound with ioban emergently flipped the patient onto his back and began chest compression.The patient was successfully resuscitated and was stable after multiple medications given.Doi: (b)(6) 2008; dor: (b)(6) 2019; right 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.

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.

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.E3 initial reporter occupation is lawyer.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: PINNACLE MTL INS NEUT44IDX66OD
• Type of Device: PINNACLE HIP SYSTEM : HIP METAL ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10638157
• MDR Text Key: 212510498
• Report Number: 1818910-2020-21659
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• PMA/PMN Number: K052426
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/08/2020

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
• Device Operator: Health Professional
• Device Catalogue Number: 121887466
• Device Lot Number: 2441052
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/22/2020
• Initial Date FDA Received: 10/06/2020
• Supplement Dates Manufacturer Received: 10/08/2020; 10/08/2020; 11/03/2020
• Supplement Dates FDA Received: 10/12/2020; 10/12/2020; 11/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 12/14 ARTICUL 44MM M SPEC+1.5; PINN CAN BONE SCREW 6.5MMX25MM; PINN CAN BONE SCREW 6.5MMX25MM; PINNACLE MTL INS NEUT44IDX66OD; PINNACLE SECTOR II CUP 66MM; SUMMIT POR TAPER SZ8 HI OFF
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR