MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE SECTOR II CUP 52MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Model Number 1217-22-052

Device Problem Loss of Osseointegration (2408)

Patient Problems Unspecified Infection (1930); Inflammation (1932); Necrosis (1971); Inadequate Osseointegration (2646); No Code Available (3191)

Event Date 03/13/2014

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.Occupation: lawyer.

Event Description

After review of medical records, the patient was revised to address septic loosening.Operative findings include inflammatory tissues, loose cup as well as stem, a large fluid collection within the joint and necrotic tissue.Revision implants are from depuy.Antibiotic-laden cement was used on the acetabulum and femoral canal.These were removed 3 months after as planned with no complications.

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.H6 patient code: no code available (3191) used to capture the fat necrosis.

• Brand Name: PINNACLE SECTOR II CUP 52MM
• 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: 8688121
• MDR Text Key: 147630830
• Report Number: 1818910-2019-95731
• Device Sequence Number: 1
• Product Code: MRA
• UDI-Device Identifier: 10603295009825
• UDI-Public: 10603295009825
• Combination Product (y/n): N
• PMA/PMN Number: P077026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 03/13/2014

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 Expiration Date: 08/01/2021
• Device Model Number: 1217-22-052
• Device Catalogue Number: 121722052
• Device Lot Number: 132104
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/21/2019
• Initial Date FDA Received: 06/11/2019
• Supplement Dates Manufacturer Received: 10/28/2020
• Supplement Dates FDA Received: 10/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR
• Patient Weight: 81