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

Catalog Number UNK HIP FEMORAL HEAD

Device Problem Naturally Worn (2988)

Patient Problems Foreign Body Reaction (1868); Unspecified Infection (1930); Inflammation (1932); Necrosis (1971); Pain (1994); Tissue Damage (2104); Cramp(s) (2193); Anxiety (2328); Depression (2361); Ambulation Difficulties (2544); Limited Mobility Of The Implanted Joint (2671); Test Result (2695); No Code Available (3191)

Event Date 03/31/2015

Event Type  Injury  

Manufacturer Narrative

(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- (b)(4).Ongoing post market surveillance is conducted per our procedures for this product.Initial reporter occupation: lawyer.(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

Claim letter alleges metallosis, pain, cramps abductors region, excessive chromium and cobalt ion due to wear and tear of the prosthesis.Ultrasound reported cylindrical shaped periprosthetic effusion doi: (b)(6) 2008; dor: (b)(6) 2015; left hip.

Event Description

Claim letter alleges defective and toxic implant resulted depression, fear, infection, inflammation, foreign body reaction, detachment of the prosthesis, necrotic periprosthetic tissue, walking difficulty, limited mobility and joint range of motion.However, loosening were not coded since it was not mention what component was detachment.

• Brand Name: UNKNOWN HIP FEMORAL HEAD
• Type of Device: HIP FEMORAL HEAD
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• Manufacturer (Section G): LEEDS MFG & MATERIAL WAREHOUSE; st anthonys road; leeds LS11 8DT; UK LS11 8DT
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 8518672
• MDR Text Key: 142079851
• Report Number: 1818910-2019-90792
• Device Sequence Number: 1
• Product Code: KXA
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL HEAD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/11/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR