MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN HIP FEMORAL STEM

Catalog Number UNK HIP FEMORAL STEM

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pulmonary Embolism (1498); Pain (1994); Swelling (2091); Tissue Damage (2104); Limited Mobility Of The Implanted Joint (2671)

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.Occupation: attorney.

Event Description

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 10/14/2014 for high metal ions and possible pseudotumor (never confirmed).Lab results from (b)(6) 2014 indicated both cobalt and chromium levels were above 7ppb.Update 4/2/2015 pfs and medical records received.After review of the medical records for mdr reportability, the part numbers are being updated for the head/liner.Pfs alleges that if metal ion levels don't decrease after left hip revision ((b)(4)) that the patient would be revised for the high metal ions for the right hip.At this time no repeat lab levels have been provided (dated after the dor for the left hip) so the stem isn't being reported for high metal ions.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.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the 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.H10 additional 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.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 will be filed as appropriate.

• Brand Name: UNKNOWN HIP FEMORAL STEM
• Type of Device: HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 8607296
• MDR Text Key: 144944905
• Report Number: 1818910-2019-93352
• 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
• Report Date: 04/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL STEM
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 144