MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE 100 ACET CUP 48MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Catalog Number	121701048
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pulmonary Embolism (1498); Pain (1994); Scar Tissue (2060); Tissue Damage (2104); Discomfort (2330); Limited Mobility Of The Implanted Joint (2671)
Date of Event	05/10/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint #: (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Occupation: attorney.
Event or Problem Description
Litigation alleges pain and general litigation notes metal on metal implications.Doi: (b)(6) 2006; dor: (b)(6) 2016; (left hip).Update ad 04 mar 2019: receipt of pfs, medical records and sticker sheets.In addition to what were previously alleged, pfs alleges discomfort, limited mobility and walking difficulty.After review of medical records, it was stated that the patient was revised to address pain and elevated seram metal ions.Mri showed some synovitis.Revision notes reported some scar tissues and disruption of the anterior portion of the gluteus medius.Metal ion levels were above 7ppb.Ppf alleges metal wear, metallosis and embolism after first revision.
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.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.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, a follow-up medwatch will be filed as appropriate.

• Brand Name: PINNACLE 100 ACET CUP 48MM
• Common Device Name: PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 8469075
• Report Number: 1818910-2019-89129
• Device Sequence Number: 1664119
• Product Code: LPH
• UDI-Device Identifier: 10603295008538
• UDI-Public: 10603295008538
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K000306
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2006
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2019

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/08/2009
• Device Catalogue Number: 121701048
• Device Lot Number: Y2PCB1000
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/04/2019
• Supplement Date Received by Manufacturer: 12/03/2019
• Initial Report FDA Received Date: 04/01/2019
• Supplement Report FDA Received Date: 12/30/2019
• 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: Other
• Patient Age: 57 YR
• Patient Weight: 112