MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 UNKNOWN HIP ACETABULAR CUP

Catalog Number UNK HIP ACETABULAR CUP

Device Problems Loss of Osseointegration (2408); Naturally Worn (2988); Noise, Audible (3273)

Patient Problems Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Necrosis (1971); Pain (1994); Test Result (2695); No Code Available (3191)

Event Date 07/11/2019

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, "host-specific factors affect the pathogenesis of adverse reaction to metal debris" written by lari lehtovirta, aleski reito, olli lainiala, jyrki parkkinen, harry hothi, johann henckel, alister hart, and antti eskelinen published by bmc musculoskeletal disorders published 2019 was reviewed.The article's purpose to assess whether the development of armd (adverse reaction to metal debris) is actually affected by host-specific intrinsic factors.Data was compiled from 29 patients with bilateral revision of depuy asr mom hips (58 hips).It is noted that 24 patients had depuy asr xl thas but the femoral stem is not identified.It is unknown if these patients had bilateral thas or if a combination of hra and tha was utilized for these patients.The article does not provide adequate information to determine accurate quantities.All revisions were for armd with some patients receiving revision to one side at the first revision and the contralateral hip revised at the 2nd revision verse bilateral revisions at the same revision.The intraoperative findings and subjective reports are captured as adverse events in this complaint.Depuy products: asr head, asr cup, asr xl head, asr xl sleeve (augment), asr xl cup.Adverse events: revision for armd attributed to mom bearing wear.Reports of pain.Aseptic cup loosening.Elevated metal ion levels.Pseudotumor.Sense of instability.Sounds from hip (clacking, squeaking).Soft tissue necrosis via histopathological analysis.

Manufacturer Narrative

Product complaint #: (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review was not possible because the required lot code(s) was not provided.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Corrective action was not indicated.

• Brand Name: UNKNOWN HIP ACETABULAR CUP
• Type of Device: HIP ACETABULAR CUP
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• MDR Report Key: 10308497
• MDR Text Key: 199988110
• Report Number: 1818910-2020-16518
• Device Sequence Number: 1
• Product Code: KWA
• 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: 07/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP ACETABULAR CUP
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/04/2020
• 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