MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD. 8010379 UNKNOWN HIP FEMORAL AUGMENT

Catalog Number UNK HIP FEMORAL AUGMENT

Device Problem Insufficient Information (3190)

Patient Problems Erosion (1750); Inflammation (1932); Pain (1994); Tissue Damage (2104); Distress (2329); Injury (2348); Test Result (2695); Not Applicable (3189)

Event Date 08/31/2016

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.Is an attorney.

Event Description

Asr litigation and medical received.Litigation alleges injuries.After review of the medical records for mdr reportability, patient was revised to address metallosis.Revision notes reported of a thickened and inflamed bursa over posterior lateral hip and show some gross signs of metal staining with brown discoloration.There was also inflamed synovial tissue in the joint, which grossly appeared to have metallosis.The 43mm head was removed from the depuy summit stem and obvious metallosis was noted at the trunnion with black reactive deposits.The acetabular bone was noted to be significantly involved with lytic erosion and was brown fibrinous material.It was also stated that patient had an asr components implanted on (b)(6) 2007 and (b)(6) 2007.However, there are no primary surgery notes provided to confirm the correct doi for each affected side.Should there be new information, this complaint will be updated.Doi: unknown ; dor: (b)(6) 2016; left hip.

Manufacturer Narrative

Product complaint # :(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

In addition to what was previously reported, litigation alleges pain.

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.(b)(4)/2018 additional information received.No device associated with this report was received for examination.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.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.

• Brand Name: UNKNOWN HIP FEMORAL AUGMENT
• Type of Device: HIP FEMORAL AUGMENT
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD. 8010379; st. anthony's rd; leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer (Section G): DEPUY INTERNATIONAL LTD. 8010379; st. anthony's rd; leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, PA 19380 ; 6103142063
• MDR Report Key: 7748815
• MDR Text Key: 115981588
• Report Number: 1818910-2018-65732
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/06/2018

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL AUGMENT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/06/2018
• Initial Date FDA Received: 08/03/2018
• Supplement Dates Manufacturer Received: 07/06/2018; 11/27/2018; 04/19/2019
• Supplement Dates FDA Received: 08/03/2018; 12/27/2018; 05/15/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-1749/1816-2011
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 47 YR