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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. ZIMMER ALL POLY PATELLA 35MM PROSTHESIS, KNEE

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ZIMMER MANUFACTURING B.V. ZIMMER ALL POLY PATELLA 35MM PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Rupture (2208)
Event Date 06/20/2017
Event Type  Injury  
Manufacturer Narrative

(b)(4). Concomitant medical products: persona size e tibia, catalog #: 42532007101, lot #: 63189523; zimmer persona posterior stabilized fixed bearing polyethylene articular surface size 10mm left, catalog #: 42512400710, lot #: 62762730; zimmer nexgen lps-flex tivanium femur size f, catalog #: 00596801651, lot #: 63506651. It was indicated by the complainant that the product would not be returned to zimmer biomet for evaluation, as the device remains implanted. The product was evaluated through manufacturing review and the reported event was confirmed through review of medical records. The devices history records were reviewed and no discrepancies relevant to the reported event were identified. Review of medical records provided identified at least one fall since the patient's procedure in (b)(6) 2017. There was palpable defect noted in the medial retinaculum with pretibial edema, erythema and obvious lateral subluxation. The operative report confirms that the patient suffered from left knee retinacular disruption with continuous left knee pain. After soft and hard tissue resections, it was observed that there was no evidence of infection, but that there was an obvious traumatic disruption of the retinaculum at the level of the vastus medialis oblique extending to the inferior pole of the retinaculum. The edges of the retinaculum were debrided sharply down to normal tissue, vancomycin powder was used and the retinaculum was repaired. Per the package insert for the persona knee, pain is one of the known adverse effects of the tka procedure. Compatibility of the implants was also reviewed, and per the package insert for nexgen cr-flex and lps-flex knees, nexgen femoral components are not compatible with persona articular surfaces or tibial components. However, a definitive root cause of the tendon tear and pain leading to retinaculum repair or effect of the off-label use of the nexgen femur cannot be determined. 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. Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2018-03859. This report was previously submitted erroneously on apr 6, 2018 and may 22, 2018 under manufacturing report number 0001822565-2018-02049.

 
Event Description

It is reported that the patient underwent a left knee retinaculum repair two months following her last left knee procedure due to retinacular rupture and increased pain. The patient relayed she had fallen once since her last procedure. No additional patient consequences were reported.

 
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Brand NameZIMMER ALL POLY PATELLA 35MM
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 Key7751459
MDR Text Key116053346
Report Number0002648920-2018-00580
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 COMPANY REPRESENTATIVE,CONSUM
Reporter Occupation
Type of Report Initial
Report Date 07/20/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/06/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number42540000035
Device LOT Number63432243
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 Received07/09/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/05/2016
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: 08/06/2018 Patient Sequence Number: 1
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