MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE 300 ACET CUP 58MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Catalog Number	121703058
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Infarction, Cerebral (1771); Pain (1994); No Code Available (3191)
Date of Event	10/02/2013
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.(b)(4).Occupation: attorney.
Event or Problem Description
Litigation alleges that patient experienced persistent pain and a popping sensation in hip.Update (b)(6) 2013 - the complaint has been updated because it was reported that the patient's left hip was revised (b)(6) 2013.The report states that the patient was asymptomatic, but family, due to negative press, wanted his metal liner swapped out for a poly liner.Also, patient's attorney insists the his is asr; however, all documentation proves otherwise.Update 12/19/2014- pfs and medical records received.Pfs now alleges high metal ions and metallosis.After review of the medical records for mdr reportability, the revision operative note indicated high metal ions (lab results from (b)(6) 2011) support this.The stem is being added for the high metal ions.There was no mention of metallosis.Update ad 20 jun 2018: receipt of ppf and implant records.In addition to what previously alleged, ppf alleges stroke and heart attack before first revision.Added cup to address stroke and heart attack.
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 300 ACET CUP 58MM
• 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: 8349740
• Report Number: 1818910-2019-84966
• Device Sequence Number: 2284365
• Product Code: LPH
• UDI-Device Identifier: 10603295008682
• UDI-Public: 10603295008682
• 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: 2006
• Device Explanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2019

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 Catalogue Number: 121703058
• Device Lot Number: Z31FX1000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/05/2019
• Supplement Date Received by Manufacturer: 12/17/2019
• Initial Report FDA Received Date: 02/19/2019
• Supplement Report FDA Received Date: 12/31/2019
• 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: 71 YR
• Patient Weight: 100