MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARTICULAR SURFACE FIXED BEARING POSTERIOR STABILIZED (PS) RIGHT 10 MM HEIGHT; PROSTHESIS, KNEE

Model Number N/A

Device Problem Noise, Audible (3273)

Patient Problems Pain (1994); Swelling (2091)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Attempts have been made and additional information on the reported event is unavailable at this time.It is unknown if product will be returning to zimmer biomet and 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: xxxx, yyy 0001822565-2018-03104, 0001822565-2018-03105, 0001822565-2018-03106.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 patient underwent right knee arthroplasty.Subsequently patient started experiencing pain, swelling, and a clicking sound within the past year.

Event Description

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

Manufacturer Narrative

Reported event was unable to be confirmed due to limited information received from the customer.Visual and dimensional evaluations could not be performed as the product was not returned.Dhr was reviewed and no discrepancies relevant to the reported event were found.Per the persona knee system package insert, pain and swelling are known potential adverse effects of this procedure.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report 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: persona tibial stem, catalog #: 42532007102, lot #: 63078059, persona articular surface, catalog #: 42522400710, lot #: 62470557, persona femoral, catalog #: 42500006602, lot #: 62467375, persona all poly patella, catalog #: 42540000035, lot #: 62933431, persona 2.4mm female screw, catalog #: 42509902525, lot #: 63110246, headless trocar drill pin, catalog #: 00590102000, lot #: 63133660, palacos lv&g cement, catalog #: 00111914001, lot #: 76644362.H3: customer has indicated product will not be returned to zimmer biomet for investigation as the product remains implanted.The investigation is in process.Once the investigation is completed, a follow-up report will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0002648920-2019-00200, 0001822565-2018-03104, 3007963827-2019-00072, 0001822565-2019-01135.If any further information is found which would alter or change any conclusions or information, a supplemental will be submitted accordingly.Zimmer biomet will continue to monitor for trends.H3 other text : device remains implanted in patient.

• Brand Name: ARTICULAR SURFACE FIXED BEARING POSTERIOR STABILIZED (PS) RIGHT 10 MM HEIGHT
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7577180
• MDR Text Key: 110321837
• Report Number: 0001822565-2018-03104
• 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: 05/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2018
• Device Model Number: N/A
• Device Catalogue Number: 42522400710
• Device Lot Number: 62470557
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/14/2019
• 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: 54