MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE MTL INS NEUT44IDX64OD; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR LINERS

Catalog Number 121887464

Device Problem Naturally Worn (2988)

Patient Problems Foreign Body Reaction (1868); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 12/09/2020

Event Type  Injury  

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 Description

It was reported as metal on metal hip that mri showed effusion.Soft tissues were stained with metal debris.Pinnacle metal liner explanted and replaced with poly liner.Patient had elevated cobalt levels.Doi: unknown; dor: (b)(6) 2020; affected side: left hip.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.Review of the singular provided x-ray image finds nothing indicative of a product problem.The image does not aid in determining a root cause for the reported allegations.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: (b)(4), it has been determined that should related reports be identified an mre is not required.Corrected h6 health effect - clinical code: appropriate term / code not available (e2402) from the initial medwatch to capture blood heavy metal increased.

• Brand Name: PINNACLE MTL INS NEUT44IDX64OD
• 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: 11051401
• MDR Text Key: 223056299
• Report Number: 1818910-2020-27405
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• PMA/PMN Number: K083642
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 12/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 121887464
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 12/14 ARTICUL 44MM M SPEC-2; UNKNOWN HIP FEMORAL STEM; 12/14 ARTICUL 44MM M SPEC-2; UNKNOWN HIP FEMORAL STEM
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR
• Patient Weight: 108