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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER, INC. ARTICULAR SURFACE FIXED BEARING POSTERIOR STABILIZED (PS) PROSTHESIS, KNEE

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ZIMMER, INC. ARTICULAR SURFACE FIXED BEARING POSTERIOR STABILIZED (PS) PROSTHESIS, KNEE Back to Search Results
Catalog Number 42522400510
Device Problems Pitted (1460); Naturally Worn (2988); Insufficient Information (3190)
Patient Problems Pain (1994); Loss of Range of Motion (2032)
Event Date 04/17/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4). Concomitant medical products: catalog #: 42-5000-060-02, psn fem ps cmt ccr nrw sz 6 r, lot # 62992927, catalog #: 42-5320-067-02, psn tib np stm 5 deg sz d r, lot # 63387012, catalog #: 42-5402-000-32, all poly pat ve 32 mm dia, lot # 62946938. The reported event could not be confirmed based on limited information received. No products were returned; therefore, the visual and dimensional inspections were not performed. Device history record (dhr) was reviewed and no discrepancies were found. Review of the complaint history determined that no further action is required. Compatibility check noted no issues. The packaging insert for personalized knee system states that poor range of motion is considered to be known adverse effects of the procedure. A definitive root cause cannot be determined with the information provided. No corrective actions, preventive actions, or field actions resulted after investigation of this event. 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.
 
Event Description
It was reported that the reason for the revision surgery is patient's extremely limited range of motion and pain. No additional information is available at this time.
 
Manufacturer Narrative
(b)(4). The complaint device has been returned, but the device investigation has not yet been completed. Once the evaluation is completed, a supplemental medwatch 3500a will be submitted.
 
Event Description
It was further reported the patient underwent a revision due to patient's contracture along with soft tissue release. Patient's knee was also noted to be warm to touch. The surgeon also thought the patient had synovitus. The surgeon performed a synovectomy and replaced the articular surface with the custom implant. However, the knee was loose and unstable. Therefore, the surgeon changed the implant to an 8mm implant. This provided good stability. The surgeon further noted the removed articular surface showed evidence of pitting and wear lines most likely from third body. Attempts have been made and additional information on the reported event is unavailable.
 
Manufacturer Narrative
(b)(4). This follow-up report is being submitted to relay additional information. Complaint sample was evaluated and the reported event was not confirmed. Visual inspection of returned device shows signs of wear (nicked, gouged, wear) and the dovetail feature is flared. The dimensional analysis was performed and found to be conforming. Device history record (dhr) was reviewed and no discrepancies were found. The packaging insert for personalized knee system states that poor range of motion is considered to be known adverse effects of the procedure. A definitive root cause cannot be determined with the information provided. 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.
 
Event Description
No further event information available at the time of this report.
 
Manufacturer Narrative
(b)(4). Concomitant medical products: catalog #: 42-5000-060-02, psn fem ps cmt ccr nrw sz 6 r, lot # unk, catalog #: 42-5320-067-02, psn tib np stm 5 deg sz d r, lot # unk, catalog #: 42-5402-000-32, all poly pat ve 32 mm dia, lot # unk. Customer has indicated that the product will not be returned to zimmer biomet for investigation due to device still being implanted in the patient. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It was reported that the patient was experiencing constant pain after their right knee arthroplasty. The patient will undergo a revision procedure.
 
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Brand NameARTICULAR SURFACE FIXED BEARING POSTERIOR STABILIZED (PS)
Type of DevicePROSTHESIS, KNEE
Manufacturer (Section D)
ZIMMER, INC.
1800 west center street
warsaw IN 46580
Manufacturer (Section G)
ZIMMER, INC.
1800 west center street
warsaw IN 46580
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key6710057
MDR Text Key134225050
Report Number0001822565-2017-04863
Device Sequence Number1
Product Code OIY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PK121771
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 03/19/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/13/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/31/2020
Device Catalogue Number42522400510
Device Lot Number63249567
Other Device ID Number(01) 00889024243590
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/30/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/13/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/15/2016
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: 07/13/2017 Patient Sequence Number: 1
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