MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 SROM 28MM +0 M HEAD; S-ROM FEMORAL HEADS (11/13) : HIP METAL FEMORAL HEADS

Catalog Number 136516500

Device Problems Material Disintegration (1177); Naturally Worn (2988)

Patient Problems Host-Tissue Reaction (1297); Cardiac Arrest (1762); Pain (1994); Discomfort (2330); Deformity/ Disfigurement (2360); Osteolysis (2377); Limited Mobility Of The Implanted Joint (2671); Test Result (2695); No Code Available (3191)

Event Date 03/28/2016

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Patient code: no code available ((b)(4)) used to capture the surgical intervention and emotional distress.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Litigation alleged debilitating pain, discomfort, disfiguration, soreness, which negatively affecting her ability to perform activities of daily living, emotional distress, and friction and wear between cobalt-chromium metal head and chromium metal liner caused toxic cobalt-chromium.

Manufacturer Narrative

(b)(4).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, a follow-up medwatch will be filed as appropriate.

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.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.

Event Description

Ppf alleges metallosis.Pfs alleges bone deterioration, high levels of cobalt levels, heart attack 4 weeks after surgery, pain and limb asymmetry.After review of medical records, patient was revised on mar 28, 2016 due to osteolysis from metal debris with possible secondary infection with obviously what appeared to be an infected, a prostalac cement was implanted.On (b)(6) 2016, patient was revised due removal prostalac.Added medical history, law firm, surgeon, patient height and weight.Updated unknown products and affected side.

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.   udi (b)(4).

• Brand Name: SROM 28MM +0 M HEAD
• Type of Device: S-ROM FEMORAL HEADS (11/13) : HIP METAL FEMORAL HEADS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8050789
• MDR Text Key: 126522634
• Report Number: 1818910-2018-74938
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• PMA/PMN Number: K851422
• 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: 10/19/2018

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 Expiration Date: 09/30/2009
• Device Catalogue Number: 136516500
• Device Lot Number: 1806811
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/19/2018
• Initial Date FDA Received: 11/08/2018
• Supplement Dates Manufacturer Received: 11/20/2018; 03/05/2019; 12/16/2019
• Supplement Dates FDA Received: 11/22/2018; 03/14/2019; 12/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Weight: 64