MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN HIP ACETABULAR LINERS

Catalog Number UNK HIP ACETABULAR LINER

Device Problems Naturally Worn (2988); Noise, Audible (3273)

Patient Problems Foreign Body Reaction (1868); 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 9 of a (b)(6) year old female with a r thr.The radiographic analysis reveal stem circumference osteolysis.She reported a hip click noise and incongruity (no further details of reasoning of incongruity) without note of edema 33 months post initial implantation and noted turbid milky white joint fluid color intraoperatively.Deposition of metal debris at the head-neck junction was noted as positive.Revision surgery changed bearing surfaces to mop and a stem exchange.Cross reference to narrative description indicates the stem was revised due to loosening.

Manufacturer 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 ACETABULAR LINERS
• Type of Device: HIP ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, PA 19380-0988 ; 6103142063
• MDR Report Key: 9216686
• MDR Text Key: 173206451
• Report Number: 1818910-2019-108582
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other Health Care Professional
• 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 ACETABULAR LINER
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/19/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR