MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD. 8010379 DEPUY ASR XL FEM IMP SIZE 43; HIP FEMORAL HEAD

Catalog Number 999890143

Device Problems Loss of or Failure to Bond (1068); Insufficient Information (3190)

Patient Problem Pain (1994)

Event Date 02/06/2014

Event Type  Injury  

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.

Event Description

New etq record created in order to update etq (legacy system) complaint number (b)(4).Reason for original complaint - (b)(4).Asr - revision due to cup loosening.Implant date: (b)(6) 2006.Revision date (b)(6) 2011.Update received 6th febuary, 2014.Hip side and surgeon added.Implant date and surgery date amended.(b)(4) number added.Country amended to (b)(6) in line with claimsuite.Lot number amended for femoral head.Hip(s) to be revised: left dint 17890 has been found to be a duplicate of dint 19632.Documents transferred to this com and additional reference number and surgeon added.Update 28 oct 2015: added pain from claimsuite, any missing mw fields, man/exp dates for all products.Sm 3 nov 2015.

Manufacturer Narrative

New etq record created in order to update etq (legacy system) complaint number (b)(4).Reason for original complaint ¿ clinical study (b)(4); patient ref (b)(6).Asr - revision due to cup loosening.Implant date (b)(6) 2006; incorrect see below.Revision date (b)(6) 2011; incorrect see below.Update received 6th febuary, 2014.Hip side and surgeon added.Implant date and surgery date amended.Dp47 number added.Country amended to germany in line with claimsuite.Lot number amended for femoral head.Hip(s) to be revised: left (b)(4) has been found to be a duplicate of (b)(4).Documents transferred to this com and additional reference number and surgeon added.Update 28 oct 2015: added pain from claimsuite, any missing mw fields, man/exp dates for all products.Sm 3 nov 2015 update august 17, 2017 additional information received from crawford, as per review of the new information there is no update to the com.The reported event has been evaluated and will be monitored.Depuy considers the investigation closed at this time.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.

Manufacturer Narrative

Depuy considers the investigation closed at this time.Should the 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: DEPUY ASR XL FEM IMP SIZE 43
• Type of Device: HIP FEMORAL HEAD
• 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: chad gibson ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743725905
• MDR Report Key: 5235680
• MDR Text Key: 31597967
• Report Number: 1818910-2015-35464
• Device Sequence Number: 1
• Product Code: KXA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Attorney
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 10/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/25/2010
• Device Catalogue Number: 999890143
• Device Lot Number: 1852423
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/23/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/09/2005
• 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: 60 YR