MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA ALL POLY PATELLA; PROSTHESIS, KNEE

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Muscular Rigidity (1968); Pain (1994); Limited Mobility Of The Implanted Joint (2671); Cancer (3262)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: unknown tibial component 13mm catalog #: unknown lot #: unknown, unknown articular surface 8mm catalog #: unknown lot #: unknown, unknown femoral component size e catalog #: unknown lot #: unknown.The complainant has indicated that the product will not be returned because it remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filled for this patient; please see all reports associated with this event: 0001822565-2019-04974, 0001822565-2019-04975, 0001822565-2019-04976, 0001822565-2019-05072.Remains implanted.

Event Description

It was reported that the patient underwent a knee arthroplasty.Subsequently, the patient was experiencing pain in knee and had limited range of motion.No revision procedure has been reported to date.However, the patient has been doing additional physical therapy.Attempt for further information has been made, but no further information has been provided.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

Udi #: (b)(4).Concomitant medical products: persona femur cemented posterior stabilized (ps) standard catalog # 42500606402 lot # 63362725, persona stemmed tibia catalog # 42532007102 lot # 63315961, persona articular surface fixed bearing posterior stabilized (ps) catalog # 42522400713 lot # 63029895, 3.5mm hex head screw x38mm catalog # 20800000018 lot # unknown.Multiple mdr reports were filled for this event: 3007963827-2020-00037.3007963827-2020-00038.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, g4, g7, h1, h2, h3, h6, h10 reported event was unable to be confirmed due to limited information received from the customer.Device was not returned.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not 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.

Event Description

No further event information available at the time of this report.

• Brand Name: PERSONA ALL POLY PATELLA
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9375550
• MDR Text Key: 168052784
• Report Number: 0001822565-2019-05072
• Device Sequence Number: 1
• Product Code: OIY
• Combination Product (y/n): N
• PMA/PMN Number: K121771
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup,Followup
• Report Date: 03/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2021
• Device Model Number: N/A
• Device Catalogue Number: 42540200035
• Device Lot Number: 63326893
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 83