MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNK ULNAR COMPONENT; PROSTHESIS, EXTREMITIES

Catalog Number UNKNOWN ULNAR COMPONENT

Device Problems Malposition of Device (2616); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Arthritis (1723); Fall (1848); Bone Fracture(s) (1870); Failure of Implant (1924); Reaction (2414)

Event Date 10/16/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, associated reports: 0001825034-2020-03873.2014, exact date is unknown.Unk humeral component.Foreign - event occurred in (b)(6).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.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 an initial elbow procedure approximately six (6) years ago.Subsequently, the patient was revised approximately three (3) years ago due to a periprosthetic fracture and loosening caused by falling.Attempts have been made and no further information has been provided.

Manufacturer Narrative

No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Insufficient information provided.Unable to perform a compatibility check.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: aseptic loosening, periprosthetic fracture, ulnar stem outside medullary canal, patient has been symptomatic since 2014, posterior approach, olecranon and coronoid process arthritic, moderate blood loss, duration of surgery 200 minutes, no intra-operative complications listed.Op record: no infection, metallosis effect on soft tissue, ulnar component malpostioned outside medullary canal, ulnar perforated in 2 areas proximally and distally from prior operation.Implant is loose.Humeral implant loose, fracture at tip of the stem.Part and lot identification are necessary for review of device history records, neither were provided.A definitive root cause cannot 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 further event information available at the time of this report.

Event Description

Additional information was received and it was reported the patient experienced metallosis on the soft tissue.Additionally, it was reported the ulnar component was malpositioned outside the medullary canal.

Manufacturer Narrative

The event is still under investigation.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: UNK ULNAR COMPONENT
• Type of Device: PROSTHESIS, EXTREMITIES
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10720612
• MDR Text Key: 212780930
• Report Number: 0001825034-2020-03872
• Device Sequence Number: 1
• Product Code: JDC
• Combination Product (y/n): N
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 11/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN ULNAR COMPONENT
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: NI
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 74