MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PSN FEM CR CMT CCR STD SZ 8 R; PROSTHESIS, KNEE

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

(b)(4).Concomitant medical product: unknown persona patella.Unknown persona tibial tray.Unknown persona bearing.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.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: 0001822565-2017-07445, 0001822565-2017-07446, 0001822565-2017-07447, 0001822565-2017-07448.Remains implanted.

Event Description

It was reported on maude report that the patient is experiencing constant pain, which began after initial implantation.It was also reported that the patient had fallen due to the knee giving out.A replacement surgery has been scheduled on an unknown date.No additional patient consequences were reported.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated: reported event was unable to be confirmed as part number / lot number of device involved in the incident is unknown.Dhr review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not 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.

Manufacturer Narrative

The follow-up report is being submitted to relay additional information.Additional concomitant medical products: palacos bone cement, catalog#: 00111214001 lot#: 80414395.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 on a maude report that the patient is experiencing constant pain, which began after initial implantation.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.

Manufacturer Narrative

Cmp-(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: (b)(4).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.- attachment: [cmp-(b)(4) additional information ((b)(4) 2018).Pdf].

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.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.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.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Concomitant products: 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.

Event Description

It was further reported that patient experienced subsidence and instability.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.Dhr was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause cannot be determined with the information provided.A summary of the investigation has been sent to the complainant.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.

• Brand Name: PSN FEM CR CMT CCR STD SZ 8 R
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6979903
• MDR Text Key: 90330480
• Report Number: 0001822565-2017-07446
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK172524
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 11/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 42-5026-064-02
• Device Lot Number: 62830391
• Other Device ID Number: (01) 00889024230385
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/10/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/14/2014
• 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; Required Intervention
• Patient Age: 73 YR
• Patient Weight: 91