MAUDE Adverse Event Report: ZIMMER BIOMET, INC. OSS FINN MOD PROX FMRL LT 7CM; PROSTHESIS, HIP

Model Number N/A

Device Problems Material Deformation (2976); Difficult or Delayed Separation (4044)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/08/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical devices: item #: unknown, unknown head lot #: unknown; item #: unknown, unknown competitor liner lot #: unknown; item #: unknown, unknown competitor cup lot #: unknown; 150393 oss porous im stem 249710; 150464 oss 3cm diaphysel segment 258720; 150461 oss 3cm ellip diaphyseal 519620; 150483 oss segmental stacking 281540; 6704-8-240 stryker cable 2.0mm 40620305; 6704-4-020 stryker cable sleeve 41165504.Customer has indicated that the product will not be returned to zimmer biomet for investigation.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: 0001825034 - 2021 - 00445.

Event Description

It was reported patient underwent left tha on unknown date, and underwent revision with all components explanted.The patient underwent a 2nd revision.During the revision it was noted that a screw was stripped and that the interbody segment had cold welded to distal segmental component.The interbody segment was able to be removed.The stem was solid and thus retained.No additional information is available.

Event Description

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

Manufacturer Narrative

(b)(4) this follow-up report is being submitted to relay additional information.Updated: b4, b5, d4, g2, g3, h2, h3, h4, h6 reported event was confirmed by review of medical records.Device history record (dhr) was reviewed and no discrepancies related to the event were found.Root cause was unable to be determined.Medical records identified the following: attempted to remove screw from proximal body and was stripped, high speed bur attempted next and unable to remove, used cutting bur to remove the proximal segment of the proximal femoral replacement.Attempted to remove the interbody segment to shorten the limb, and found it had cold welded onto most distal segment, used high speed metal cutting bur to split segment and was able to disengage the interbody segment.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.

• Brand Name: OSS FINN MOD PROX FMRL LT 7CM
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11313319
• MDR Text Key: 231380546
• Report Number: 0001825034-2021-00444
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• PMA/PMN Number: K002757
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor,health p
• Type of Report: Initial,Followup
• Report Date: 06/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2022
• Device Model Number: N/A
• Device Catalogue Number: 150458
• Device Lot Number: 605670
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/21/2021
• Initial Date FDA Received: 02/11/2021
• Supplement Dates Manufacturer Received: 06/02/2021
• Supplement Dates FDA Received: 06/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 44 YR