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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE MTL INS NEUT36IDX50OD PINNACLE HIP SYSTEM : HIP METAL ACETABULAR LINERS

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DEPUY ORTHOPAEDICS INC US PINNACLE MTL INS NEUT36IDX50OD PINNACLE HIP SYSTEM : HIP METAL ACETABULAR LINERS Back to Search Results
Catalog Number 121887350
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Osteolysis (2377)
Event Date 10/18/2021
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
It was reported that on (b)(6) 2010, the patient underwent the tha surgery with the insert in question, other company¿s cup (pinnacle-a) and a s-rom a. After the surgery, the revision surgery was planned on (b)(6) 2021. It was found that osteolysis occurred around the proximal femur. Since the sleeve was well fixed, the sleeve was left as it was, and the stem and the head were replaced with new ones. The cup was other company¿s product, and it was replaced with a zimmer biomet¿s product. The revision surgery was completed successfully with no surgical delay. The surgeon commented that osteolysis occurred due to mom. Doi: (b)(6) 2010; dor: (b)(6) 2021; unknown side.
 
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Brand NamePINNACLE MTL INS NEUT36IDX50OD
Type of DevicePINNACLE HIP SYSTEM : HIP METAL ACETABULAR LINERS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
Manufacturer (Section G)
DEPUY INT'L LTD. 8010379
st anthonys road
leeds LS11 8 DT
UK LS11 8 DT
Manufacturer Contact
kara ditty-bovard
700 orthopaedic dr.
warsaw, IN 46581-0988
6107428552
MDR Report Key12711068
MDR Text Key278763116
Report Number1818910-2021-23850
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 10/18/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/28/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number121887350
Device Lot Number3069333
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/30/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/11/2010
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: 10/28/2021 Patient Sequence Number: 1
Treatment
9/10 ULTAMET 36MM HEADS +3; COMPETITOR CUP; SROM 9/10 16X10X130 30; UNK HIP ACETABULAR CUP PINNACLE
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