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

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 # 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.

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.

• Brand Name: ARTICULAR SURFACE FIXED BEARING POSTERIOR STABILIZED (PS)
• Type of Device: PROSTHESIS, 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 Key: 6710057
• MDR Text Key: 79907199
• Report Number: 0001822565-2017-04863
• Device Sequence Number: 1
• Product Code: OIY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK121771
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Physician
• 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 Received: 07/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2020
• Device Catalogue Number: 42522400510
• Device Lot Number: 63249567
• Other Device ID Number: (01) 00889024243590
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/13/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/15/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 51 YR
• Patient Weight: 65