MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD. 8010379 TAPER SLEEVE ADAPTER 12/14 +2; HIP FEMORAL STEM/SLEEVE

Catalog Number 999800102

Device Problem Loss of or Failure to Bond (1068)

Patient Problem No Information (3190)

Event Date 07/02/2012

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 - right hip.Asr xl + s-rom.Reason(s) for revision: s-rom implant broken.Patient lawyer informed crawford broadspire on (b)(6) 2012: an aseptic breakage of the stem was diagnosed.X-rays and operative notes confirm this.Pinnacle and corail implants were implanted at the revision.Resurfacing to xl patient - this is the 2nd of 2 revisions.See com (b)(4) for the 1st revision of the resurfacing head.(b)(4) rejected as a duplicate.Notification received (b)(6) 2013, advising: (b)(6) was born on (b)(6) 1952.She is (b)(6).Our medics noted she weighed (b)(6) kg at implant surgery and (b)(6) at explant surgery (bmi of (b)(6)).We have no knowledge of her sports activities.Update received: (b)(6) 2014 - added (b)(4), added hospitals: (b)(6), cross referenced, clarified implant dates and advised that previous attachment advised component loosening - taper sleeve.Cup implanted: (b)(6) 2005.Xl products implanted: (b)(6) 2007.All products revised: (b)(6) 2012.

Manufacturer 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.Ref.(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.

• Brand Name: TAPER SLEEVE ADAPTER 12/14 +2
• Type of Device: HIP FEMORAL STEM/SLEEVE
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD. 8010379; st. anthony's rd; leeds LS11 8 D; UK LS11 8 DT
• Manufacturer (Section G): DEPUY INTERNATIONAL LTD. 8010379; st. anthony's rd; leeds LS11 8 D; UK LS11 8 DT
• Manufacturer Contact: stacey trick ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743714554
• MDR Report Key: 3671407
• MDR Text Key: 4344598
• Report Number: 1818910-2014-14017
• Device Sequence Number: 1
• Product Code: KXA
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Patient
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 02/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Catalogue Number: 999800102
• Device Lot Number: 2396190
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/20/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/08/2007
• 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
• Patient Weight: 59