MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 LARGE MOD HEAD ADAPT 12/14 +5; ASR HIP SYSTEM : HIP FEMORAL SLEEVE

Catalog Number 999800105

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Tissue Damage (2104); Heart Failure (2206)

Event Date 12/21/2010

Event Type  Injury  

Manufacturer Narrative

Product complaint #: (b)(4).Investigation summary: revision of the device has been reported and there was no allegation that the device was a contributor to this event.No explanted devices have been received in respect of this patient for analysis.Manufacturing records have been reviewed and the device(s) met specification prior to placing on the market.If further information is received indicating that the device was a contributor or there is an alleged deficiency of the device then this event will be re-opened for evaluation.Device history lot: a review of manufacturing records of lot 2116508 did not identify any anomalies.(b)(4) products manufactured and placed into stock on 25 feb 2006.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.

Event Description

Complaint description: (b)(4).Reason for original complaint: asr revision, asr xl acetabular system (right), reason(s) for revision: pain.(b)(4) received 4th june 2014.(b)(4) received 5th june 2014.Surgeon initials and title added.Taper sleeve and stem added.Additional reasons for revision added.Reason(s) for revision: pain, alval / soft tissue reaction, limp.Update ad 25 oct 2018: (b)(4) has been re-opened under (b)(4).Complaint re-opened to document that the claimant is now deceased.There is no allegation that the cause of death is related to the asr device.Added patient initials.Doi: (b)(6) 2006; dor: (b)(6) 2011; right hip.

• Brand Name: LARGE MOD HEAD ADAPT 12/14 +5
• Type of Device: ASR HIP SYSTEM : HIP FEMORAL SLEEVE
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• Manufacturer (Section G): DEPUY INT'L LTD. 8010379; st. anthony's rd; leeds LS11 8DT; UK LS11 8DT
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988
• MDR Report Key: 8381647
• MDR Text Key: 137519652
• Report Number: 1818910-2019-86156
• Device Sequence Number: 1
• Product Code: KXA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,other
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 02/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 999800105
• Device Lot Number: 2116508
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/19/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/15/2006
• Is the Device Single Use?: No
• 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): Death
• Patient Age: 58 YR