MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. PERSONA TIB STM 5 DEG SZ E 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

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.Mw5072178.Product location unknown.

Event Description

It was reported that a patient underwent an initial right knee procedure.Pain occurred constantly since the day after surgery.Patient returned to physician several times to find cause of pain.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, subsidence and instability.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Mw5070268-3 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.

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

(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: PERSONA TIB STM 5 DEG SZ E R
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• MDR Report Key: 7645908
• MDR Text Key: 112592058
• Report Number: 0002648920-2018-00516
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• PMA/PMN Number: PK172524
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 42532007102
• Device Lot Number: 63078072
• Other Device ID Number: (01) 00889024471061
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 73 YR
• Patient Weight: 91