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

Catalog Number UNK HIP FEMORAL AUGMENT

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

Patient Problems Dyspnea (1816); Pain (1994); Rash (2033); Test Result (2695); No Code Available (3191)

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.

Event Description

Literature article entitled, ¿arthro prosthetic cobaltism: neurological and cardiac manifestations in two patients with metal-on-metal arthroplasty¿ was reviewed for mdr reportability.The article reviewed two cases of asr xl implants.The first case is captured on a linked pc.Case 2 of 2: (b)(6) years-old male received revision 40 months post previous revision.Initial implantation and specific product related to initial implantation not clarified.On year after post first revision patient harms reported: cognitive decline, vertigo, hearing loss, groin pain, rashes, dyspnea, elevated cobalt (co) levels ranging 23 mcg/l intra-operative findings with second revision: metallosis.Product related findings: acetabular cup wear, femoral head wear.

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.Further investigation of this individual incident will not be undertaken.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 road; leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer (Section G): DEPUY INTERNATIONAL LTD. 8010379; st anthonys road; leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, PA 19380 ; 6107428552
• MDR Report Key: 8786427
• MDR Text Key: 150883514
• Report Number: 1818910-2019-98203
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/26/2019

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?: Yes
• Initial Date Manufacturer Received: 06/26/2019
• Initial Date FDA Received: 07/12/2019
• Supplement Dates Manufacturer Received: 07/22/2019
• Supplement Dates FDA Received: 07/25/2019
• 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
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention