MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. US 1818910 UNKNOWN HIP FEMORAL HEAD

Catalog Number UNK HIP FEMORAL HEAD

Device Problems Nonstandard Device (1420); Naturally Worn (2988)

Patient Problems Foreign Body Reaction (1868); Pain (1994); Tissue Damage (2104); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).No 510(k) number provided because this implant is sold internationally with different indications for use; it is currently sold in the us under a different part number.The correction/removal reporting number listed applies to the corresponding product code sold domestically.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

An article ¿cobalt from metal-on-metal hip replacements may be the clinically relevant active agent responsible for periprosthetic tissue reactions¿ by alister j.Hart et al reports on difference in the relative amounts of implant-derived metals in the tissues and in the chemical speciation of the debris.It was performed through an ex vivo analysis of periprosthetic capsular tissue from 12 patients in two groups, ultima and non-ultima (5 females and 1 male, median age=27) that included two resurfacing asr and one modular asr during revision of mom hips (insitu for atleast 18 months) that failed without evidence of infection or a mechanical problem such as dislocation or impingement during the period february 2008 to september 2010.Reason for revision was unexplainable pain for all cases.No clarification was found on which events were specifically present on specific patients.2 cases of pseudotumors and one case of partial avulsion of the gluteus medius tendon were reported in non-ultima group in which asr was used.Synchrotron x-ray analysis of periprosthetic tissue revealed that co (in either the metallic or 2+ oxidation states) may be the clinically relevant active species derived from mom hips that is responsible for unexplained failures due to tissue inflammation.The relative amount of co, when compared with cr, and visible corrosion was found on the ultima femoral stems.

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.Additional narrative: product complaint # (b)(4).Investigation summary no device was received.Root cause undetermined.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may 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 FEMORAL HEAD
• Type of Device: HIP FEMORAL HEAD
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. US 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8865815
• MDR Text Key: 153429879
• Report Number: 1818910-2019-100205
• Device Sequence Number: 1
• Product Code: KXA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 08/02/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL HEAD
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-1749/1816-2011
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention