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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC 1818910 PINN MAR NEUT 32IDX52OD PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS

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DEPUY ORTHOPAEDICS INC 1818910 PINN MAR NEUT 32IDX52OD PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS Back to Search Results
Catalog Number 121932052
Device Problem Disassembly
Event Date 05/15/2018
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.

 
Event Description

Business unit: depuy (b)(4) date j&j became aware: (b)(4) 2018, date of event: (b)(6) 2018, name of reporter: (b)(6), hospital name: (b)(6), product name: pinnacle, product code:121932052, lot/batch/exp: c79076. Was the product being used in a clinical trial? no. Did the event happen during a procedure? no. Were you in the procedure at the time of the event? no. Event outcome/how was it managed? poly liners was replaced and a new head implanted. Was there any consequence to the patient due to the event? yes failure to be mobile due to liner dislocation. Was the surgery prolonged due to the event? no. Has the reporter facility indicated there may be legal action? no. Is the product available for return? no. Please give a detailed explanation of the event: the patient was operated on (b)(6) 2017. For 6 months everything was fine but presented in jan with a clucking hip. This occurred after the patient jarred his hip while hiking. The surgeon stated the liner had dislocated and the locking mechanism for the poly did not appear damaged. Hence he replaced the poly liner and head. All appeared to seat well and reduced the hip. It was a left hip, the primary and revision were performed by mr (b)(6). Some metallosis was seen however on inspection the surgeon was happy with the locking mechanism. The implants were a pinnacle shell 52 mm, 32mm neutral liner and +5mm 32mm head. Replaced with (b)(4) lot d18020202; (b)(4) lot hn8096; (b)(4) lot 8717901.

 
Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. Product complaint #:(b)(4). Investigation summary :depuy synthes considers the investigation closed at this time. Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.

 
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Brand NamePINN MAR NEUT 32IDX52OD
Type of DevicePINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC 1818910
700 orthopaedic drive
warsaw IN 46582 0988
Manufacturer (Section G)
DEPUY ORTHOPAEDICS INC 1818910
700 orthopaedic drive
warsaw IN 46582 0988
Manufacturer Contact
chad gibson
700 orthopaedic drive
warsaw , IN 46582-0988
5743725905
MDR Report Key7595991
Report Number1818910-2018-62025
Device Sequence Number1
Product CodeLPH
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup
Report Date 05/15/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/13/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number121932052
Device LOT NumberC79076
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 Received08/01/2018
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured09/12/2016
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: 06/13/2018 Patient Sequence Number: 1
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