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

Catalog Number UNK HIP FEMORAL HEAD

Device Problem Naturally Worn (2988)

Patient Problems Edema (1820); Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Pain (1994); Loss of Range of Motion (2032); Osteolysis (2377); No Code Available (3191)

Event Date 08/28/2016

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.(b)(4).

Event Description

The literature article entitled, "failure rates of asian-type anatomic medullary locking stemmed metal-on-metal total hip replacement: a cause for adverse tissue reactions to metal debris (armd)" written by masaru nakamura, tateaki shimakawa, shunji nakano, takashi chikawa, shinji yoshioka, masahiro kashima, shunichi toki, hidehisa horiguchi, and koichi sairyo published by journal of orthopaedic science 21 (2016) 779e785 published only 28 august 2016 was reviewed for mdr reportability.The purpose of the article: " to examine the incident rate of armd, and the implant survival rate as well as to compare the armd group and non-armd group." the article reports on 23 individual cases that received initial depuy product mom thrs between february 2007 and november 2009 of which 14 required revision due to reported pain suspected armd and 9 who did not receive revision but treated conservatively for unexplained hip pain and/or swelling.The non-revision cases had no particular findings, and symptoms subsided by conservative treatment of nonsteroidal anti-inflammatory drugs and anti-allergic agents.Each case is captured individually within linked complaints.All cases received aml-a plus stem, ultamet metal insert, ultamet head and pinnacle cup.All patients who received revision had bacterial culture inspections that were negative for infections but all were diagnosed with armd with note of debris including 13 of the 14 with deposition of metal debris at the head-neck junction.This complaint captures revision case 2 of a (b)(6) year old male with a l thr.The ct detected a solid mass and cup circumference osteolysis.He reported pain and limited extension range of motion with note of lower extremity swelling 20 months post initial implantation and noted turbid ash gray joint fluid color intraoperatively.Deposition of metal debris at the head-neck junction was noted as positive.Revision surgery changed bearing surfaces to mop plus a cup exchange.By cross reference to narrative description, this case also was revised due to cup loosening and was found to have extensive necrotic tissue due to deliberating to consent for revision surgery.

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.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.The complaint shall be closed with an undetermined conclusion; entered into the complaints database and monitored through trend analysis.Post market surveillance is per sep 419.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 HEAD
• Type of Device: HIP FEMORAL HEAD
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9216690
• MDR Text Key: 163117848
• Report Number: 1818910-2019-109306
• 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,literature
• Type of Report: Initial,Followup
• Report Date: 10/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2019
• 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: 12/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR