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

Device Problem Malposition of Device (2616)

Patient Problems Edema (1820); Pain (1994); Tissue Damage (2104); Discomfort (2330); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)

Event Date 04/05/2010

Event Type  Injury  

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.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 Description

Litigation alleges that patient suffered from severe pain and discomfort in his left hip.The pain has been continuous and has significantly interfered with his normal daily activities.Doi: (b)(6) 2006.Dor: (b)(6) 2010; (right hip).Part/ lot information was identified.Records are available if needed for further review.Medical records confirm the product placement in the right hip.Update ad 20 jun 2018: (b)(4) has been re-opened under (b)(4) due to the receipt of ppf and sticker sheets record.Ppf has no new allegation.Added facility name, lawyer, products expiration and udi.Doi: (b)(6) 2006.Dor: (b)(6) 2010; (right hip).Patient is bilateral, please see (b)(4) for the left hip.

• Brand Name: PINNACLE 300 ACET CUP 52MM
• Type of Device: PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic drive; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 9860317
• MDR Text Key: 188693763
• Report Number: 1818910-2020-08748
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295008651
• UDI-Public: 10603295008651
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K001534
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/11/2012

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 1217-03-052
• Device Catalogue Number: 121703052
• Device Lot Number: AF7DE1000
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/02/2020
• Initial Date FDA Received: 03/20/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/21/2006
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 43 YR
• Patient Weight: 72