MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNK HINGE PIN; PROSTHESIS, EXTREMITIES

Catalog Number UNK HINGE PIN

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Ossification (1428); Failure of Implant (1924); Osteolysis (2377)

Event Date 05/22/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).(b)(6).Report source: 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 approximately three (3) months ago, patient was implanted with a coonrad morrey elbow.Subsequently, patient experienced loosening of the hinge pin and was hospitalized.It is unknown whether the patient was revised or not.Attempts have been made and no further information has been provided.

Manufacturer Narrative

D4: part and lot combination provided by event reporter is for a subcomponent of the device.This part/lot combination was issued to several different work orders.All of the dhrs were pulled so a complaint history search and recall hold search could be performed for those possible work orders.Because it is unknown which exact work order belongs to this reported event, the complaint will remain unknown part, unknown lot.Possible part/lot combinations include: part# 00810512502, lot # 6114017, part # 88560800000, lot # 80811845, part # 32810502501, lot # 64495637, part # 32810502501, lot # 64563448, part # 32810502608, lot # 64410201, part # 32810502604, lot # 64410198, part # 32810502504, lot # 64363412, part # 32810502506,lot # 64363413.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Reported event is not related to a combination of products; therefore a compatibility review is not applicable.Medical records were not provided.Dhr was reviewed and no discrepancies relevant to the reported event were found.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

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

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: note confirmation of backed out pin (disassociation) with resultant subluxation.Bone resorption and heterotopic ossification noted as well.The root cause of the reported event has not changed.A definitive root cause cannot be determined.If any further information which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: UNK HINGE PIN
• Type of Device: PROSTHESIS, EXTREMITIES
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 10407442
• MDR Text Key: 202910066
• Report Number: 0001822565-2020-02946
• Device Sequence Number: 1
• Product Code: JDC
• Combination Product (y/n): N
• Reporter Country Code: RS
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 06/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK HINGE PIN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 88 KG