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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. PERSONA TIB STM 5 DEG SZ E R PROSTHESIS, KNEE

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ZIMMER MANUFACTURING B.V. PERSONA TIB STM 5 DEG SZ E R PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problems Migration or Expulsion of Device (1395); Unstable (1667)
Patient Problems Bruise/Contusion (1754); Fall (1848); Inflammation (1932); Pain (1994); Skin Discoloration (2074); Burning Sensation (2146)
Event Date 11/09/2017
Event Type  Injury  
Manufacturer Narrative

Persona femoral cr: catalog#: 42-5026-064-02 lot#: 62830391, persona all poly patella: catalog#: 42-5400-000-32 lot#: 62816540, persona tibial stem: catalog#: 42-5320-071-02 lot#: 63078072, persona articular surface: catalog#: 42-5220-005-11 lot#: 62559453. Customer has indicated that the product will not be returned to zimmer biomet for investigation as the product location is unknown. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2017-07445, 0002648920-2018-00515, 0002648920-2018-00516, 0001822565-2017-07448. If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly. Zimmer biomet will continue to monitor for trends. Mw5072178. Product location unknown.

 
Event Description

It was reported that a patient underwent an initial right knee procedure. Pain occurred constantly since the day after surgery. Patient returned to physician several times to find cause of pain. It was reported that the patient had fallen due to the knee giving out. Subsequently, the patient's right knee was revised due to pain, subsidence and instability.

 
Manufacturer Narrative

(b)(4). This follow-up report is being submitted to relay additional information. Mw5070268-3 if any information is found which would change or alter any conclusions or information, a supplemental will be submitted accordingly. Zimmer biomet will continue to monitor for trends.

 
Event Description

It was further reported that patient experienced instability, frequent falls, pain, swelling, skin discoloration, burning sensation, inability to walk 100 yards, difficulty climbing steps, poor gait, feels and hears a popping sound coming from knee, inflammation, bruising, difficulty sleeping, and fluid buildup.

 
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Brand NamePERSONA TIB STM 5 DEG SZ E R
Type of DevicePROSTHESIS, KNEE
Manufacturer (Section D)
ZIMMER MANUFACTURING B.V.
turpeaux industrial park
route #1 km 123.4 bldg #1
mercedita PR 00715
Manufacturer (Section G)
ZIMMER MANUFACTURING B.V.
turpeaux industrial park
route #1 km 123.4 bldg #1
mercedita PR 00715
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key7645908
MDR Text Key112592058
Report Number0002648920-2018-00516
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberPK172524
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER,HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 11/05/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/28/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator
Device MODEL NumberN/A
Device Catalogue Number42532007102
Device LOT Number63078072
OTHER Device ID Number(01) 00889024471061
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received10/10/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/22/2015
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A

Patient TREATMENT DATA
Date Received: 06/28/2018 Patient Sequence Number: 1
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