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

Catalog Number 999890146

Device Problems Loss of Osseointegration (2408); Insufficient Information (3190)

Patient Problems Host-Tissue Reaction (1297); Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Pain (1994); Tissue Damage (2104); No Code Available (3191)

Event Date 12/20/2016

Event Type  Injury  

Manufacturer Narrative

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.Ww(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

Patient underwent a revision to address component loosening and pain.

Manufacturer Narrative

Depuy still considers the investigation closed.Should additional information be received the investigation will be reopened.

Event Description

Update - alert date 30 jan 2017 ** (b)(6) confirmed there was no component loosening.Reasons for revision : alval / soft tissue reaction / pain / large pseudotumor.

Manufacturer Narrative

Asr revision, asr xl, left, reason(s) for revision: component loosening, pain.Update - alert date 30 jan 2017.Crawfords confirmed there was no component loosening.Reasons for revision : alval / soft tissue reaction / pain / large pseudotumor.Amended patient harms and failure code, taken from attachment dated 30 jan 2017.Update aug 15, 2017: email notification from (b)(6) received.There is no new information.This complaint was updated on: aug 22, 2017.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

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.This hip replacement platform was voluntarily recalled from the market and the product codes are now considered inactive.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.H10 additional narrative: added: d4 (udi), d11 and h6 (patient codes).H6 patient code: no code available (3191) used to capture the device revision or replacement.

• 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 rd; leeds, leeds LS11 8 DT; UK LS11 8 DT
• MDR Report Key: 6253107
• MDR Text Key: 64921481
• Report Number: 1818910-2017-10917
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/21/2016

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: 999890146
• Device Lot Number: 2380004
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/21/2016
• Initial Date FDA Received: 01/16/2017
• Supplement Dates Manufacturer Received: Not provided; 08/24/2017; 08/17/2020
• Supplement Dates FDA Received: 02/17/2017; 09/06/2017; 08/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-1749/1816-2011
• Patient Sequence Number: 1
• Treatment: ASR ACETABULAR IMPLANT 52; CORAIL2 STD SIZE 11; LARGE MOD HEAD ADAPT 12/14 +5
• Patient Outcome(s): Required Intervention