MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 PINN SECTOR W/GRIPTION 62MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Model Number	1217-32-062
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Osseointegration Problem (3003)
Health Effect - Clinical Codes	Unspecified Infection (1930); Inadequate Osseointegration (2646); No Code Available (3191)
Date of Event	12/20/2016
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
Subject: (b)(6).Clinical adverse event received for migration / loosening of the acetabular shell.Event is serious and is considered severe.Event is possibly related to both device and procedure.Revision of shell, liner and head has occurred.Doi: (b)(6) 2012; doe: (b)(6) 2016; dor: (b)(6) 2016; (right hip).
Additional 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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional 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. udi: (b)(4).
Event or Problem Description
Ppf alleges dislocation with closed reduction and infection.
Additional 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.Additional narrative: added evaluation codes (patient code).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Patient code: no code available (3191) used to capture the patient code medical device removal.
Additional 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.H10 additional narrative: added: h6 (patient).No code available (3191) to capture surgical intervention.

• Brand Name: PINN SECTOR W/GRIPTION 62MM
• Common Device Name: PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7291789
• Report Number: 1818910-2018-53973
• Device Sequence Number: 1177588
• Product Code: JDI
• UDI-Device Identifier: 10603295010357
• UDI-Public: 10603295010357
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K093646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 02/01/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/30/2021
• Device Model Number: 1217-32-062
• Device Catalogue Number: 121732062
• Device Lot Number: 181963
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/01/2018
• Supplement Date Received by Manufacturer: 08/10/2018; 05/14/2019; 10/30/2019; 08/12/2020
• Initial Report FDA Received Date: 02/23/2018
• Supplement Report FDA Received Date: 08/30/2018; 05/21/2019; 11/15/2019; 08/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR
• Patient Weight: 104