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

Catalog Number UNK HIP ACETABULAR LINER

Device Problems Difficult to Remove (1528); Device-Device Incompatibility (2919)

Patient Problems Pain (1994); Osteolysis (2377); No Code Available (3191)

Event Date 03/06/2016

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, "chemistry-driven structural alterations in short-term retrieved ceramic-on-metal hip implants: evidence for in vivo incompatibility between ceramic and metal counterparts" written by wenliang zhu, giuseppe pezzotti, marco boffelli, thanainit chotanaphuti, saradej khuangsirikul, and nobuhiko sugano published by journal of biomedical materials research b: applied biomaterials | aug 2017 vol 105b, issue 6 on 25 march 2016 was reviewed for mdr reportability.The article's purpose: "in this article, we shall present some new spectroscopic evidence obtained from two short-term retrieval cases of zirconia-toughened alumina (zta) ceramic heads, which were applied in vivo against metal cup liners." each case is captured individually on separate complaints.Both cases were implanted with com bearings of depuy pinnacle cup with ultamet metal insert and a ceramic femoral head.No identification provided for stem but it is reasonable to conclude the femoral stem was also a depuy product utilized in conjunction with the majority identified depuy products.This complaint captures case 1 of a (b)(6) female with tha in january 2010.Three years post op she developed thigh pain and progressive osteolysis around femoral stem.In the impossibility of removing the isolated metal liner during revision surgery, the com prosthesis had to be explanted in full and replaced with conventional mop one.No indication if debris was present.

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, 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: 9187631
• MDR Text Key: 173015720
• Report Number: 1818910-2019-109493
• Device Sequence Number: 1
• Product Code: KWA
• 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: 09/25/2019

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?: 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
• Initial Date Manufacturer Received: 09/25/2019
• Initial Date FDA Received: 10/14/2019
• Supplement Dates Manufacturer Received: 12/17/2019
• Supplement Dates FDA Received: 12/20/2019
• 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