MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE 300 ACET CUP 52MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Model Number	1217-03-052
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Pain (1994); Loss of Range of Motion (2032); Inadequate Osseointegration (2646); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)
Date of Event	01/10/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Initial reporter occupation: lawyer.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
Litigation alleges patient suffers from elevated ions.Update 04/10/2017.Pfs and medical records received.Pfs alleges hip, leg, lower back pain, damage to tissues, impaired walking, sitting, standing ability, impaired balance, loss of motion and uneven gait.After review of medical records for mdr reportability, it was indicated that the patient had pseudotumor and small amount of fluid distending the left greater trochanteric bursa.Date of revision was provided but no revision operative notes provided.No laboratory findings provided for alleged high metal ions.Update 09 oct 2018: (b)(4) has been re-opened under (b)(4) due to receipt of ppf and sticker sheets.In addition to what previously alleged, ppf alleges loosening of cup and fracture (bone and component).Doi: (b)(6) 2006.Dor: (b)(6) 2017, left hip.
Additional Manufacturer Narrative
This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H1 additional 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: PINNACLE 300 ACET CUP 52MM
• 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: 9081916
• Report Number: 1818910-2019-105193
• Device Sequence Number: 19564032
• Product Code: LPH
• UDI-Device Identifier: 10603295008651
• UDI-Public: 10603295008651
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: K001534
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2006
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/06/2016

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 Model Number: 1217-03-052
• Device Catalogue Number: 121703052
• Device Lot Number: AD3GEA000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/28/2019
• Supplement Date Received by Manufacturer: 06/15/2020
• Initial Report FDA Received Date: 09/18/2019
• Supplement Report FDA Received Date: 06/16/2020
• 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: 63 YR
• Patient Weight: 102