MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 PINNACLE 300 ACET CUP 50MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Model Number	1217-03-050
Medical Device Problem Codes	Loss of Osseointegration (2408); Malposition of Device (2616)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330); Inadequate Osseointegration (2646); No Code Available (3191)
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.(b)(4).
Event or Problem Description
Litigation papers allege following the surgery, patient suffered from severe pain and discomfort in her right hip.Update ad 3 may 2018 receipt of ppf and sticker sheets record.In addition to what were previously alleged, ppf alleges elevated metal ions and loosening of cup.
Additional Manufacturer Narrative
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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional 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.H10 additional narrative: added b5, b7 and h6.
Event or Problem Description
Fter review of medical records, it was indicated that the patient has been complaining of pain.Physician notes reported that the acetabular component with questionable loosening.Cup is vertical with mom bearing placing it at high risk for metallosis/psuedotumor.She has mechanical symptoms.Additional visit notes reported that the cup appears as though it may be loose, however has not moved or migrated.She does have a mom hip with mildly elevated metal ions.

• Brand Name: PINNACLE 300 ACET CUP 50MM
• 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: 8173457
• Report Number: 1818910-2018-78476
• Device Sequence Number: 1358965
• Product Code: LPH
• UDI-Device Identifier: 10603295008644
• UDI-Public: 10603295008644
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K000306
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/12/2020

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: 08/31/2020
• Device Model Number: 1217-03-050
• Device Catalogue Number: 121703050
• Device Lot Number: E3EFD1000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/26/2018
• Supplement Date Received by Manufacturer: 05/14/2019; 02/12/2020
• Initial Report FDA Received Date: 12/18/2018
• Supplement Report FDA Received Date: 05/14/2019; 03/04/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention