MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE 100 HA ACET CUP 54MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Model Number 1217-11-054

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

Patient Problems Foreign Body Reaction (1868); Joint Disorder (2373); No Code Available (3191)

Event Date 02/25/2020

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

The case was a head and liner exchange for impingement.Details ¿ implants insitu.Were ceramic on ceramic, cup was mal-positioned causing impingement and squeaking.Upon dissection noticed metallosis from stem neck impinging on rim of cup.Removed ceramic liner and head and replaced with a +4 neutral poly liner and ts ceramic head.Implant details for extraction and insertion attached.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the 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 codes).Product complaint#: (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution.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.Corrective action was not indicated.Device history lot: null.Device history batch: null.Device history review: null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Product complaint # (b)(4).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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Additional information received 30.03.2020 - the patients x-rays were not provided to the company due to confidentiality, however i can say from my own observations that the cup was excessively closed and anteverted in comparison to ideal recommended cup placement.

• Brand Name: PINNACLE 100 HA ACET CUP 54MM
• 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: 9831859
• MDR Text Key: 186516015
• Report Number: 1818910-2020-07881
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295009078
• UDI-Public: 10603295009078
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 02/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1217-11-054
• Device Catalogue Number: 121711054
• Device Lot Number: 424260
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DELTA CER HEAD 12/14 36MM +5; EA DELTA CER INSERT 36IDX54OD; PINNACLE 100 HA ACET CUP 54MM; SUMMIT DUOFIX TAP SZ2 HI OFF
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR