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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US TRI-LOCK BPS SZ 1 STD OFFSET TRILOCK HIP STEM : HIP FEMORAL STEM

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DEPUY ORTHOPAEDICS INC US TRI-LOCK BPS SZ 1 STD OFFSET TRILOCK HIP STEM : HIP FEMORAL STEM Back to Search Results
Model Number 1012-04-010
Device Problems Osseointegration Problem (3003); Migration (4003)
Patient Problems Pain (1994); Inadequate Osseointegration (2646)
Event Date 01/27/2021
Event Type  Injury  
Manufacturer Narrative
Product complaint # (b)(4). If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
Compass case (b)(4) report: it was reported that the stem subsided. Implant loosening was also noted of the trilock component-noncemented. The sale rep was contacted by the surgeon that she had a trilock implanted some time ago that had subsided in one of her patients. She did say that the patient missed their post-op office visit. She showed back up with a painful hip. She explained the stem had subsided and she wanted to revise it to a stryker and have liners available for exchange for the pinnacle cup. The pinnacle liner was exchanged and the stem and head was revised to stryker. The ref: (b)(4) lot: 39030g pinnacle altrx liner 36mm/52mm was used to replace the old liner. The 52mm pinnacle porocoat shell ref:(b)(4) lot:c43763 was left in patient. Doi: (b)(6) 2016; dor: (b)(6) 2021; affected side: right hip.
 
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Brand NameTRI-LOCK BPS SZ 1 STD OFFSET
Type of DeviceTRILOCK HIP STEM : HIP FEMORAL STEM
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
Manufacturer (Section G)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic dr.
warsaw IN 46581 0988
Manufacturer Contact
kara ditty-bovard
700 orthopaedic dr.
warsaw, IN 46581-0988
6107428552
MDR Report Key12438024
MDR Text Key270273428
Report Number1818910-2021-19544
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P070026
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 01/27/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/08/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1012-04-010
Device Catalogue Number101204010
Device Lot Number745560
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/09/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/03/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 09/08/2021 Patient Sequence Number: 1
Treatment
ALTRX NEUT 36IDX52OD; DELTA CER HEAD 12/14 36MM +5; PINNACLE SECTOR II CUP 52MM; TRI-LOCK BPS SZ 1 STD OFFSET
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