MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE SECTOR II CUP 60MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Model Number 1217-22-060

Device Problems Use of Device Problem (1670); Malposition of Device (2616)

Patient Problems Edema (1820); Foreign Body Reaction (1868); Pain (1994); Tissue Damage (2104); Joint Disorder (2373); No Code Available (3191)

Event Date 06/18/2019

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 records received.After review of medical records, the patient was revised to address pain.Lab results taken on (b)(6) 2019 indicate that blood chromium and cobalt levels were below 7.Laboratory studies were suggestive of trunnions.Operative findings include a fascial rent, metallosis-appearing fluid, trunnions and notching in the femoral neck area due to impingement between the femoral neck and acetabular socket.The cup has significant anteversion.Doi: (b)(6) 2009.Dor: (b)(6) 2019; (right hip).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: corrected: h6 (device) product complaint # (b)(4).Investigation summary
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> 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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: PINNACLE SECTOR II CUP 60MM
• 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: 9872110
• MDR Text Key: 188492343
• Report Number: 1818910-2020-09041
• Device Sequence Number: 1
• Product Code: KWA
• UDI-Device Identifier: 10603295009863
• UDI-Public: 10603295009863
• Combination Product (y/n): N
• PMA/PMN Number: K073504
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 03/06/2020

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 Expiration Date: 06/30/2019
• Device Model Number: 1217-22-060
• Device Catalogue Number: 121722060
• Device Lot Number: DX2EB1000
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/06/2020
• Initial Date FDA Received: 03/24/2020
• Supplement Dates Manufacturer Received: 04/23/2020
• Supplement Dates FDA Received: 04/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: HEAD 136506000/2922764; HOLE ELIMINATOR 124603000/DX1KY1000; LINER 121887460/2888062; SCREW 121725500/DS2DW4000; SCREW 121735500/C56FM4000; STEM 157001150/DA6D21000
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR