MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE SECTOR II CUP 62MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Model Number 1217-22-062

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

Patient Problems Edema (1820); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Discomfort (2330); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)

Event Date 10/26/2019

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

Medical record received and claim letter received.After review of medical record, patient was revised to address periprosthetic joint infection status post modular revision right thr.There was a large volume of blood tinged minimally cloudy serous fluid.Tissue was inflamed.Liner and head were removed.Patient had a minor leg length discrepancy.Claim letter alleges pain, discomfort and lack of mobility from the affected hip.Doi: (b)(6) 2019.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.Removed code for device revision or replacement and replaced with no code available (3191) for surgical intervention.

• Brand Name: PINNACLE SECTOR II CUP 62MM
• Type of Device: PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10260635
• MDR Text Key: 198440602
• Report Number: 1818910-2020-15587
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295009870
• UDI-Public: 10603295009870
• Combination Product (y/n): N
• PMA/PMN Number: K000306
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 06/30/2020

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?: No
• Device Operator: Health Professional
• Device Model Number: 1217-22-062
• Device Catalogue Number: 121722062
• Device Lot Number: W79H61018
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/30/2020
• Initial Date FDA Received: 07/10/2020
• Supplement Dates Manufacturer Received: 08/12/2020
• Supplement Dates FDA Received: 08/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SUMMIT POR TAPER SZ7 HI OFF; UNKNOWN HIP ACETABULAR LINERS; UNKNOWN HIP FEMORAL HEAD; SUMMIT POR TAPER SZ7 HI OFF; UNKNOWN HIP ACETABULAR LINERS; UNKNOWN HIP FEMORAL HEAD
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR