MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 PINNACLE SECTOR II CUP 48MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Catalog Number 121722048

Device Problem Malposition of Device (2616)

Patient Problems Foreign Body Reaction (1868); No Code Available (3191)

Event Date 07/17/2019

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 that the patients original surgery from what she said was about 15 years ago on her right hip, surgeon unknown.Patient sees surgeon for problem.In surgery, the surgeon notices that the cup was malpositioned, in antiversion and was a metal liner as well as a metal head, all removed.Patient also showed metallosis.There were also 2 screwed removed but sizes were not noted.A 58mm multi hole gription cup was implanted also with 4- 6.5mm screws 30mm, 25mmx2 and 15mm.A 40 mm neutral liner as well as a 40mm ts+5 ceramic head was implanted.The patient was put through rom and then started closing.Doi: about 15 years ago; 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.Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot number was not provided.Based on previous investigations, this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: PINNACLE SECTOR II CUP 48MM
• Type of Device: PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8865829
• MDR Text Key: 153425907
• Report Number: 1818910-2019-100204
• Device Sequence Number: 1
• Product Code: MRA
• UDI-Device Identifier: 10603295009801
• UDI-Public: 10603295009801
• Combination Product (y/n): N
• PMA/PMN Number: P070026
• 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: 07/17/2019

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: 121722048
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/17/2019
• Initial Date FDA Received: 08/06/2019
• Supplement Dates Manufacturer Received: 08/15/2019
• Supplement Dates FDA Received: 08/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SCREW; SCREW; SCREW; SCREW
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR
• Patient Weight: 78