MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE 100 ACET CUP 60MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Catalog Number	121701060
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Inflammation (1932); Pain (1994); Discomfort (2330); No Code Available (3191)
Date of Event	06/22/2012
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (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.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.
Event or Problem Description
New etq record created in order to update etq legacy system complaint number (b)(4).Reason for original complaint.- litigation alleges severe pain, discomfort, inflammation, and elevated levels of cobalt chromium metal ions and particles in the blood and tissue surrounding the implant.Doi: (b)(6) 2003; - dor: none reported; ( right side).Patient is a resident of (b)(6).Update: 11/8/2012 pfs was received from legal, medical records were received from legal, and part/lot information was identified.Records are available for further review.Patient demographics added.Update 2/24/16-pfs and medical records received.After review of the medical records for mdr reportability, a dor was provided.The revision operative note indicated metallosis and trunnionosis.The stem is being added to the complaint.Lab results indicated the metal ion levels were below 7ppb.The complaint was updated on: 3/14/2016.Update ad 26 april 2018: com-(b)(4) has been reopened under (b)(4) due to receipt of ppf and sticker sheets.  in addition to what were previously alleged, pff alleges metal wear and metallosis confirmed in the medical records.It also provided the complete patient details.Updated patient codes.Doi: (b)(6) 2003; - dor: (b)(6) 2013; (right hip).

• Brand Name: PINNACLE 100 ACET CUP 60MM
• 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: 9008024
• Report Number: 1818910-2019-104125
• Device Sequence Number: 11507421
• Product Code: LPH
• UDI-Device Identifier: 10603295008590
• UDI-Public: 10603295008590
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K000306
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2003
• Device Explanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/22/2012

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 Catalogue Number: 121701060
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/21/2019
• Initial Report FDA Received Date: 09/12/2019
• 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: Required Intervention
• Patient Age: 78 YR
• Patient Weight: 95