MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DELTA CER HEAD 12/14 36MM +5; ARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS

Catalog Number 136536320

Device Problems Material Disintegration (1177); Metal Shedding Debris (1804)

Patient Problems Unspecified Infection (1930); Pain (1994); Tissue Damage (2104); Discomfort (2330)

Event Date 01/04/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Pinnacle litigation record received.Litigation record alleges friction and wear, large amounts of toxic cobalt and chromium metal ions, pain, discomfort, functional difficulties and elevated metal levels.Doi: (b)(6) 2005; dor: not reported; left hip (pinnacle).

Manufacturer Narrative

(b)(4).No device associated with this report was received for examination.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Product complaint # (b)(4).

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.

Event Description

Update ad 7 aug 2018: (b)(4) has been re-opened due to the receipt of ppf and sticker sheets.In addition to what were previously alleged, ppf alleges infection requiring antibiotics, pseudotumor, abductor muscle repair, and metallosis.Doi: (b)(6) 2005 ¿ dor: none reported (left hip).

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.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: DELTA CER HEAD 12/14 36MM +5
• Type of Device: ARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7218133
• MDR Text Key: 98183556
• Report Number: 1818910-2018-52000
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• PMA/PMN Number: K031803
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 01/04/2018

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: 02/28/2010
• Device Catalogue Number: 136536320
• Device Lot Number: 1867279
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/04/2018
• Initial Date FDA Received: 01/25/2018
• Supplement Dates Manufacturer Received: 02/21/2018; 12/30/2018; 12/30/2018; 07/24/2019
• Supplement Dates FDA Received: 02/21/2018; 01/03/2019; 01/10/2019; 08/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR