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

Catalog Number UNK HIP ACETABULAR CUP

Device Problems Loss of Osseointegration (2408); Malposition of Device (2616); Naturally Worn (2988)

Patient Problems Cyst(s) (1800); Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Inadequate Osseointegration (2646); Test Result (2695)

Event Date 01/01/2019

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, "the 10-year outcomes of the asr xl acetabular system: a single-center experience from china" written by guojun jin, jisheng ran, weiping chen, yan xiong, jiapeng bao, and lidong wu published by journal of orthopaedic surgery and research 2019 was reviewed.The article's purpose is to assess the depuy asr xl implant design's performance with respect to: demographic characteristics of patients who underwent mom tha, the relationship between blood metal ion levels and rate of early clinical failure, the cumulative survival probability at the final follow-up, and risk factors of the revision surgery.Data was compiled from 74 prostheses followed during july 2006 to january 2010 consisting of 36 males and 38 females with age mean of 56.12 plus/minus 13.15 years.Femoral stems are not identified within the article.The article associates cystic changes, pseudotumor formation, metal staining in soft tissues related to component orientation and bearing surface wear as well as blood metal ion concentration.Figure 4 provides radiographic and ct scan of a revised asr xl mom prostheses with caption description indicating cystic changes in periprosthetic bone.Depuy products: asr xl cup, asr xl femoral head, asr xl sleeve (augment).Adverse events treated by revision: table 2 indicates mispositioned cups, cystic changes (bone related), pseudotumor formation, metal staining in gross soft tissues, loose cup, acetabular stress shielding, elevated ion levels.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : the asr platform was voluntarily recalled from the market in august 2010, and the asr product codes are now considered inactive.Further investigation of this individual incident will not be undertaken.The investigation regarding the root cause(s) and/or corrective actions was conducted under mdd capa-001226.Ongoing post market surveillance is conducted per our procedures for this product.

• 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: 10274410
• MDR Text Key: 205484562
• Report Number: 1818910-2020-15862
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2020
• 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: 08/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention