MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 PROXIMA HI OFFSET L SZ 4; PROXIMA IMPLANT : HIP FEMORAL STEM

Catalog Number 940050024

Device Problem Biocompatibility (2886)

Patient Problems Inflammation (1932); Pain (1994); Tissue Damage (2104); Limited Mobility Of The Implanted Joint (2671); Test Result (2695)

Event Date 05/15/2017

Event Type  Injury  

Manufacturer Narrative

Product complaint #: (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.Previous investigations that have included device history reviews since the asr platform was launched have shown no indication of deviations or anomalies with regard to material, manufacturing or inspection.Therefore no dhr (device history record) review for this individual asr component will be carried out at this point in time.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Pain with detrimental effects walking ability, inflammation, crepitus affecting left hip, metallosis.Doi: (b)(6) 2010; dor: (b)(6) 2017; (left hip).

• Brand Name: PROXIMA HI OFFSET L SZ 4
• Type of Device: PROXIMA IMPLANT : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• Manufacturer (Section G): DEPUY INTERNATIONAL LTD - 8010379; st anthonys road; leeds LS11 8DT; UK LS11 8DT
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr; warsaw, IN 46582 ; 6107428552
• MDR Report Key: 8577451
• MDR Text Key: 143950761
• Report Number: 1818910-2019-92384
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/30/2017

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: 940050024
• Device Lot Number: 2203110
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/12/2019
• Initial Date FDA Received: 05/03/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/25/2006
• 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: 71 YR