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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. FEMUR CEMENTED CRUCIATE RETAINING (CR) NARROW LEFT SIZE 8 PROSTHESIS, KNEE

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ZIMMER ORTHOPAEDIC MFG. LTD. FEMUR CEMENTED CRUCIATE RETAINING (CR) NARROW LEFT SIZE 8 PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Adhesion(s) (1695); Muscular Rigidity (1968); Loss of Range of Motion (2032); Limited Mobility Of The Implanted Joint (2671); Patient Problem/Medical Problem (2688)
Event Date 11/14/2017
Event Type  Injury  
Manufacturer Narrative

(b)(4). Concomitant medical products: associated products: item#:unknown; kne-unknown--art surface lot#:unknown. Item#:42540000032;all poly patella cemented 32 mm diameter lot#:63773227. Item#:00588604310; trabecular metal cruciate retaining monoblock tibial component: yellow, size 3 c-h, 10mm lot#:63564572. Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it is still implanted. 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: 0001822565-2020-01780, 0002648920-2020-00268.

 
Event Description

It was reported that the patient underwent a left total knee arthroplasty. Subsequently, the patient experienced stiffness and arthrofibrosis. The patient underwent two manipulations under anesthesia approximately 1 month and 3 months post-op. At the most recent clinic visits, the patient denied pain and was ambulating without an assistive device. Complications appear to have resolved.

 
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Brand NameFEMUR CEMENTED CRUCIATE RETAINING (CR) NARROW LEFT SIZE 8
Type of DevicePROSTHESIS, KNEE
Manufacturer (Section D)
ZIMMER ORTHOPAEDIC MFG. LTD.
building no 2 east park
shannon industrial estate
shannon, county clare
EI
Manufacturer (Section G)
ZIMMER ORTHOPAEDIC MFG. LTD.
building no 2 east park
shannon industrial estate
shannon, county clare
EI
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key10069847
MDR Text Key191399637
Report Number3007963827-2020-00142
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK172524
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation PHYSICIAN ASSISTANT
Type of Report Initial,Followup
Report Date 07/16/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/19/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number42502006401
Device LOT Number63557913
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 Received07/15/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/16/2017
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: 05/19/2020 Patient Sequence Number: 1
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