MAUDE Adverse Event Report: DEPUY ORTHOPAEDIC INC, 1818910 PINN SECTOR W/GRIPTION 66MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Catalog Number	121732066
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Infarction, Cerebral (1771); Pain (1994); Discomfort (2330)
Date of Event	05/21/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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
New unity record created in order to update legacy complaint number: (b)(4).Litigation papers allege: on or about (b)(6) 2009 patient underwent a left total hip arthroplasty procedure.Due to patient's chronic pain and discomfort and other symptoms, patient will likely need to undergo revision surgery to replace the left implant.Doi: (b)(6) 2009 - dor: none reported (left side) patient is a resident of (b)(6).Update 11/26/2012 - medical records were received.Part/lot information were identified.Pfs and sticker sheets are available on external hard drive if needed for further review.Update ad 21 may 2018: (b)(4) has been re-opened under (b)(4) due to receipt of ppf and implant sticker sheet.In addition to what were previously alleged, ppf alleges stroke and heart attack after the first revision.Doi: (b)(6) 2009; dor: not reported; left hip (3rd not revised) (b)(4) - 1st revision (left) (b)(4) - 2nd revision (left) (b)(4) - 1st revision (right) (b)(4) - 2nd not revised (right).
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.

• Brand Name: PINN SECTOR W/GRIPTION 66MM
• Common Device Name: PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS
• Manufacturer (Section D): DEPUY ORTHOPAEDIC INC, 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7621313
• Report Number: 1818910-2018-62760
• Device Sequence Number: 1383812
• Product Code: LPH
• UDI-Device Identifier: 10603295010371
• UDI-Public: 10603295010371
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K071784
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2018

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/25/2019
• Device Catalogue Number: 121732066
• Device Lot Number: DK6FH1000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/21/2018
• Supplement Date Received by Manufacturer: 08/22/2018
• Initial Report FDA Received Date: 06/20/2018
• Supplement Report FDA Received Date: 09/12/2018
• 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: 62 YR