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

Catalog Number UNK HIP ACETABULAR CUP

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Syncope (1610); Fatigue (1849); Foreign Body Reaction (1868); Nausea (1970); Pain (1994); Weakness (2145); Discomfort (2330); Depression (2361); Test Result (2695); No Code Available (3191)

Event Date 05/22/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4). No 510(k) number provided because this implant is sold internationally with different indications for use; it is currently sold in the us under a different part number.   the correction/removal reporting number listed applies to the corresponding product code sold domestically. Initial reporter occupation: lawyer. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Asr claim letter and medical records received. Claim letter alleges pain, dizziness, nausea, weakness, fainting, fatigue, discomfort, depression, post-traumatic stress disorder, prostatic adenocarcinoma these signs and symptoms and diagnosis were due to metal poisoning, heavy metals cobalt and chromium in the body. Lab reports above 7 ppb. Claimant is seeking for damages. After review of medical records the patient was revised due to mechanical complication of internal joint prosthesis resulting to metallosis, elevated metal ions, vertigo and limping. Doi: (b)(6) 2008. Dor: (b)(6) 2017 ; left hip.

• 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
• Manufacturer (Section G): DEPUY INT'L LTD. 8010379; st anthonys road; leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 9943355
• MDR Text Key: 187518799
• Report Number: 1818910-2020-10553
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: HR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,other

Reporter Occupation

• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 03/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: UNK HIP ACETABULAR CUP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 04/20/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No Answer Provided
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-1749/1816-2011

Patient Treatment Data

Date Received: 04/09/2020 Patient Sequence Number: 1