MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BIOMET SERIES A STANDARD PATELLA; PROSTHESIS KNEE

Model Number N/A

Device Problem Noise, Audible (3273)

Patient Problems High Blood Pressure/ Hypertension (1908); Pain (1994); Swelling (2091); Burning Sensation (2146); Joint Swelling (2356); Ambulation Difficulties (2544); No Code Available (3191)

Event Date 06/30/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4) concomitant medical product: unknown vanguard cr articular surface catalog # unknown lot # 243670, biomet cc cruciate tray catalog # 141233 lot # j3506997, vanguard cr femoral component catalog # 183008 lot # 33550.Cement bone simplex catalog # 6191-1-001 lot # rcv037, cement bone simplex catalog # 6191-1-001 lot # rjv119, unknown catalog # unknown lot # 808860.Customer has indicated that the product will not be returned because 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 filled for this event: 0001825034-2018-02462, 0001825034-2018-02466, 0001825034-2018-02467.

Event Description

It was reported that the patient underwent an initial knee arthroplasty.Subsequently, the patient suffered pain, stiffness, hypertension & cold sensation in the knee.There was a popping noise in the knee with burning sensation.The patient has reported difficulty in walking without a walker.

Event Description

No additional information is available at this time to report.

Manufacturer Narrative

The additional information received does not change any previously reported investigation results.

Manufacturer Narrative

The follow up report is being submitted to relay additional information received.The complaint cannot be confirmed based as no medical records were provided.The device history records were reviewed for deviations and/ or anomalies with no deviations/ anomalies identified that could lead to the reported event.Root cause was unable to be determined.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 additional information is available to report at this time.

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 report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

It was reported that the patient underwent initial knee arthroplasty.Subsequently, the patient was revised approximately 4 years post implantation due to chronic pain, cold sensation, hypertension, stiffness and swelling in the knee.The patient also experienced a popping noise in the knee with burning sensation.The patient reported difficulty due to hyper extension and cannot walk without a walker.

• Brand Name: BIOMET SERIES A STANDARD PATELLA
• Type of Device: PROSTHESIS KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7409139
• MDR Text Key: 104774964
• Report Number: 0001825034-2018-02472
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• PMA/PMN Number: PK171054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 07/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/26/2020
• Device Model Number: N/A
• Device Catalogue Number: 184766
• Device Lot Number: 049600
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Required Intervention