MAUDE Adverse Event Report: ZIMMER, INC. PSN ASF UC 14MM VE R 4-11 EF; PROSTHESIS, KNEE

Model Number N/A

Device Problems Migration or Expulsion of Device (1395); Noise, Audible (3273)

Patient Problems Pain (1994); Swelling (2091); Sleep Dysfunction (2517); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)

Event Date 07/26/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).The customer has not indicated whether the product will be returned to zimmer biomet for investigation or not.Once this information is obtained a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2017-06146 and 06147.Device location unknown.

Event Description

It was reported patient underwent right knee arthroplasty approximately 2 years ago.Subsequently patient was revised due to pain since day one, bone loss in the tibia, and loosening of the implant.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

Concomitant medical products: persona femoral component, catalog # 42502007002, lot # 62967679; persona stemmed tibia, catalog # 42532007102, lot # 63097243; all poly patella, catalog # 42540000032, lot # 62953629.Multiple mdr reports were filled for this event: (b)(4) - [(b)(4) report - mw5075299.Pdf].

Event Description

It was further reported that the patient was experiencing a clicking noise, limp, having to use crutches to ambulate, and grinding sensation which increased the pain prior to the revision procedure.It was also reported that the patient has alleged sleeping problems prior to the revision procedure.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Concomitant medical products, cr femoral, narrow, size 11, right (p/n:42502007002); stemmed 5 degree tibia, size e, right (p/n:42532007102); cr femoral, narrow, size 11, right (p/n:42502007002); stemmed 5 degree tibia, size e, right (p/n:42532007102).Reported event was unable to be confirmed as lot number of device involved in the incident is unknown.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Review of the complaint history determined that no further action is required as no were trends identified.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

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.Device history record was reviewed and no discrepancies were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.There are warnings in the package insert that this type of event can occur and risks are addressed in risk documentation.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).

Event Description

The patient was further noted to have mild effusion and popping sensation one year post-implantation.Also patient was noted to have dislocated the right knee prosthesis.During the revision procedure, the surgeon noted the tibial component and femoral component were grossly loose.Both components were removed and replaced.Attempts have been made and additional information on the reported event is unavailable.

• Brand Name: PSN ASF UC 14MM VE R 4-11 EF
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer (Section G): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6833365
• MDR Text Key: 84071932
• Report Number: 0001822565-2017-06150
• Device Sequence Number: 1
• Product Code: OIY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK121771
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 05/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 10/31/2019
• Device Model Number: N/A
• Device Catalogue Number: 42522200514
• Device Lot Number: 62871009
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/19/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/21/2014
• 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
• Treatment: UNKNOWN PERSONA FEMORAL,; UNKNOWN PERSONA PATELLA.; UNKNOWN PERSONA TIBIAL TRAY,
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 60 YR
• Patient Weight: 100