MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN DEPUY PINNACLE METAL LINER; HIP ACETABULAR INSERT/LINER

Catalog Number UNK-HIP

Device Problems Naturally Worn (2988); Insufficient Information (3190)

Patient Problems Edema (1820); Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930); Pain (1994); Swelling (2091); Tissue Damage (2104); Discomfort (2330); Ambulation Difficulties (2544); Limited Mobility Of The Implanted Joint (2671)

Event Date 03/15/2013

Event Type  Injury  

Manufacturer Narrative

Udi: unavailable.This complaint is the subject of litigation or a legal claim and currently complete product detail is not available at this time.A follow-up medwatch will be filed as appropriate.This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.

Event Description

Litigation alleges patient was revised to address pain and metallosis.

Manufacturer Narrative

Examination of the reported devices was not possible as they were not returned.The investigation can draw no conclusion regarding the reported event with the information available.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.

Manufacturer Narrative

Product complaint # (b)(4).(b)(4) is used to capture (medical device removal.

Event Description

Ppf alleges metal wear and infection.After review of medical records the patient was revised due to metallosis, pseudotumors and pseudo-membranes.Past medical history indicated that the patent have developed pain, swelling, discomfort, positive for infection and trouble ambulating.Operative note reported, there was a tremendous cavity of black lined fluid.There was a tremendous amount of anteversion of the cup, it was very stable.

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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: UNKNOWN DEPUY PINNACLE METAL LINER
• Type of Device: HIP ACETABULAR INSERT/LINER
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 6416346
• MDR Text Key: 70300467
• Report Number: 1818910-2017-14948
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/28/2017

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
• Device Operator: Health Professional
• Device Catalogue Number: UNK-HIP
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/28/2017
• Initial Date FDA Received: 03/19/2017
• Supplement Dates Manufacturer Received: Not provided; 11/26/2019; 01/10/2020
• Supplement Dates FDA Received: 04/18/2017; 12/17/2019; 01/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR
• Patient Weight: 68