MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 UNKNOWN HIP ACETABULAR CUP

Catalog Number UNK HIP ACETABULAR CUP

Device Problems Loss of Osseointegration (2408); Osseointegration Problem (3003)

Patient Problems Pulmonary Embolism (1498); Pain (1994); Swelling (2091); Tissue Damage (2104); Inadequate Osseointegration (2646); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)

Event Date 10/14/2014

Event Type  Injury  

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

Event Description

Complaint description: new (b)(4) created in order to update (b)(4) (legacy system).Complaint number: (b)(4).Reason for original complaint- bilateral patient.Litigation alleges that patient has experienced severe and constant pain and suffering, swelling, bursitis, lack of mobility, and/or metallosis.Update 11/20/2012- medical records were received and available on a disc.Records indicated doi on the left hip as (b)(6) 2004 and doi for right hip as (b)(6) 2004.Update 12/15/2014- pfs and medical records received.After review of the medical records for mdr reportability, the left hip was revised on (b)(6) 2014 for high metal ions and possible pseudotumor (never confirmed).Lab results from (b)(6) 2014 indicated both cobalt and chromium levels were above 7ppb.The mdr decisions for the metal liners are being changed to reportable at this time.There is no new additional information that would affect the existing mdr decision.The complaint was updated on: 1/27/2015.Update 4/2/15-pfs and medical records received.After review of the medical records for mdr reportability, the part numbers are being added to the head and liner.A correct doi was provided.There is no new additional information that would affect the existing mdr decision.The complaint was updated on:4/21/2015.Update ad 7 may 2018.(b)(4) was re-opened under (b)(4) due to receipt of ppf and medical records.In addition to what were previously alleged, ppf alleges pulmonary embolism and loose cup.After review of medical records it stated that the patient had doi on may 4, 2004 due to degenerative joint disease.Unknown cup has been added to the complaint.No lot numbers were provided.Added law firm and corrected doi.Doi: (b)(6) 2004; dor: (b)(6) 2014; left hip.

Manufacturer Narrative

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 HIP ACETABULAR CUP
• Type of Device: HIP ACETABULAR CUP
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, PA 19380 ; 6107428552
• MDR Report Key: 8612958
• MDR Text Key: 145147818
• Report Number: 1818910-2019-93585
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 04/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP ACETABULAR CUP
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/13/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 50 YR
• Patient Weight: 144