MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 DEPUY ASR XL FEM IMP SIZE 46; HIP FEMORAL HEAD

Catalog Number 999890146

Device Problems Nonstandard Device (1420); Device Slipped (1584)

Patient Problems Foreign Body Reaction (1868); Tissue Damage (2104)

Event Date 11/11/2014

Event Type  Injury  

Event Description

New etq record created in order to update etq (legacy system) complaint number (b)(4).Reason for original complaint - asr revision to take place on (b)(4) 2013; asr xl - right; reason(s) for revision: component loosening - cup.Update received april 23rd, 2013.Revision date added.On 24 feb 2015 - update - patient bilateral - for left hip see (b)(4) - rcvd op documents for left hip and right hip was included.Additional information added - name, gender, dob, age, hospital, new reason for revision - metallosis on 26 feb 2015 - update - rcvd email to conf that patient had heart attack and the revision was postponed until (b)(6) 2013 - email to conf the initial implant date was also (b)(6) 2005.

Manufacturer Narrative

Additional narrative: if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.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.The correction/removal reporting number listed applies to the corresponding product code sold domestically.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, as there is an ongoing investigation regarding the root cause(s) and/or corrective actions.(b)(4).Depuy considers the investigation closed at this time.Should the product and/or additional information be received, the investigation will be re-opened.

Manufacturer Narrative

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).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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: DEPUY ASR XL FEM IMP SIZE 46
• 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): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• Manufacturer Contact: chad gibson ; 700 orthpaedics drive; warsaw, IN 46582 ; 5743725905
• MDR Report Key: 4588148
• MDR Text Key: 5338074
• Report Number: 1818910-2015-15838
• Device Sequence Number: 1
• Product Code: KXA
• Combination Product (y/n): N
• Reporter Country Code: SF
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,foreign,other
• Reporter Occupation: Patient
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 02/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Catalogue Number: 999890146
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/09/2018
• 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
• Removal/Correction Number: Z-1749/1816-2011
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 49 YR