FDA.reportPublic FDA data

MAUDE MDR 9865399

MDR report key
9865399
Report number
1818910-2020-08818
Event key
0
Event type
3
Date of event
2019-10-09
Date received
2020-03-23
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MS. KARA DITTY-BOVARD
Address
700 ORTHOPAEDIC DR. WARSAW IN 46581 US
Phone
610-610-6107
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1DEPUY ASR XL FEM IMP SIZE 45ASR HIP SYSTEM : HIP METAL FEMORAL HEADSDEPUY INTERNATIONAL LTD - 8010379KXA9998901452727781R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-2301. R

Event Narratives#

N

Patient 1

(B)(4). US FDA DEVICE MDR DECISION COMPLETED. THE HEAD AND LINER ARE REPORTED FOR METAL-ON-METAL. THERE IS NO ALLEGED PATIENT HARM OR PRODUCT DEFICIENCY. IF/WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE, THE PC WILL BE UPDATED AS NEEDED. INITIAL REPORTER OCCUPATION: LAWYER. (B)(4). 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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

D

Patient 1

ASR REVISION. ASR XL: RIGHT HIP. REASON(S) FOR REVISION: UNKNOWN. DOI: (B)(6) 2010; DOR: (B)(6) 2019; RIGHT HIP.