MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 DEPUY ASR XL FEM IMP SIZE 51; ASR HIP SYSTEM : HIP METAL FEMORAL HEADS

Catalog Number 999890151

Device Problems Material Disintegration (1177); Adverse Event Without Identified Device or Use Problem (2993); Noise, Audible (3273)

Patient Problems Host-Tissue Reaction (1297); Unspecified Infection (1930); Pain (1994); Tissue Damage (2104); No Consequences Or Impact To Patient (2199); Joint Dislocation (2374); Osteolysis (2377); Inadequate Osseointegration (2646); Not Applicable (3189); No Code Available (3191)

Event Date 04/06/2017

Event Type  Injury  

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 product code was sold internationally.It was sold in the us under a different product code. .

Event Description

Asr revision.Asr xl: left hip.Reason for revision: unknown.Doi: (b)(6) 2008; dor: (b)(6) 2017; left hip.

Event Description

Surgeon confirmation form received.In addition to what was previously alleged, surgeon confirmation form alleges component loosening due to osteolytic lesion, pain, implant noise, dislocation, infection, femoral neck fracture, trauma, elevated cobalt levels, evidence of fluid periprostetic and debris reported on mars mri.Added unknown stem for the alleged elevated cobalt levels.The patient identifier has been updated.

Manufacturer Narrative

Product complaint #
=
> pc-(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, a follow-up medwatch will be filed as appropriate.

• Brand Name: DEPUY ASR XL FEM IMP SIZE 51
• Type of Device: ASR HIP SYSTEM : HIP METAL FEMORAL HEADS
• 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: chad gibson ; 700 orthopaedic drive; warsaw, IN 46582 ; 5743725905
• MDR Report Key: 7624743
• MDR Text Key: 111855573
• Report Number: 1818910-2018-62803
• Device Sequence Number: 1
• Product Code: KXA
• Combination Product (y/n): N
• Reporter Country Code: EI
• 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,Followup,Followup,Followup
• Report Date: 05/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2013
• Device Catalogue Number: 999890151
• Device Lot Number: 2593266
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/28/2018
• Date Device Manufactured: 04/05/2008
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention