MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 PINNACLE MTL INS NEUT36IDX52OD; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR LINERS

Catalog Number 121887352

Device Problem Biocompatibility (2886)

Patient Problems Unspecified Infection (1930); Test Result (2695); No Code Available (3191)

Event Date 09/05/2007

Event Type  Injury  

Manufacturer Narrative

(b)(4).Device was used for treatment, not diagnosis.Initial reporter occupation: non-healthcare professional "attorney".(b)(4).

Event Description

Patient was revised to address loosening of the stem because of infection update in addition to what were previously alleged, ppf alleges elevated metal ions.Doi: (b)(6) 2007 - dor: (b)(6) 2007 (left hip).

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 additional related reports against the provided product code/lot code combination.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 MTL INS NEUT36IDX52OD
• Type of Device: PINNACLE HIP SYSTEM : HIP METAL ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer (Section G): DEPUY INTERNATIONAL LTD. 8010379; st. anthony's rd; leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, PA 19380-XXXX ; 6107428552
• MDR Report Key: 8594710
• MDR Text Key: 144536970
• Report Number: 1818910-2019-92953
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K073504
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/08/2007

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 121887352
• Device Lot Number: 2278508
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/09/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/28/2006
• 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: 54 YR
• Patient Weight: 86