MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD. 8010379 ASR UNI FEMORAL IMPL SIZE 53; HIP FEMORAL HEAD

Catalog Number 999890253

Device Problems Corroded (1131); Degraded (1153); Appropriate Term/Code Not Available (3191)

Patient Problems Edema (1820); Injury (2348); No Information (3190); No Code Available (3191)

Event Date 02/07/2017

Event Type  Injury  

Manufacturer Narrative

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.This complaint is the subject of litigation or a legal claim and currently complete product detail is not available at this time.A follow-up medwatch will be filed as appropriate.

Event Description

Sep 21 & 27, 2017: litigation record received.Litigation alleges excessive levels of chromium and cobalt in patient's blood.This complaint was updated on.Oct 04, 2017.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Sep 21 & 27, 2017: litigation record received.Litigation alleges excessive levels of chromium and cobalt in patient's blood.This complaint was updated on.Oct 04, 2017.No device associated with this report was received for examination.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will 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.

Manufacturer Narrative

(b)(4).

Event Description

Pfs and medical records received.Pfs alleges no new information.After review of medical records for reportability, patient was revised to address failed total hip replacement secondary to asr metal on metal hip.Revision notes indicate fluid within hip, significant corrosion trunnion femoral stem, a considerable amount of black corrosion at the head ball trunnion interface and the acetabular component was removed with minimal bone loss.

Manufacturer Narrative

Product complaint # :(b)(4).Investigation summary :this hip replacement platform was voluntarily recalled from the market and the product codes are now considered inactive.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will 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.

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.¿ no code available is used to capture blood heavy metal increased and device revision or replacement.

Event Description

After review of medical records, the patient was revised due to failed total hip replacement secondary to asr metal on metal hip.Operative notes reported that there was a considerable amount of black corrosion at the head ball trunnion interface.Operative findings also reported that there was fluid within the hip.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.This hip replacement platform was voluntarily recalled from the market and the product codes are now considered inactive.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.

• Brand Name: ASR UNI FEMORAL IMPL SIZE 53
• Type of Device: HIP FEMORAL HEAD
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD. 8010379; st. anthony's rd; leeds IN LS11 8 DT; UK LS11 8 DT
• MDR Report Key: 6964639
• MDR Text Key: 89818737
• Report Number: 1818910-2017-26978
• Device Sequence Number: 1
• Product Code: KXA
• Combination Product (y/n): N
• PMA/PMN Number: K040627
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 09/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/04/2012
• Device Catalogue Number: 999890253
• Device Lot Number: 2344575
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-1749/1816-2011
• Patient Sequence Number: 1
• Treatment: ADAPTER SLEEVES 12/14 +5; ASR ACETABULAR CUPS 60; SUMMIT DUOFIX TAP SZ7 STD OFF
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 65 YR