MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 3.5 MM LOCKING DUAL COMPRESSION PLATE 6 HOLES 79 MM LENGTH; PLATE, FIXATION, BONE

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Non-union Bone Fracture (2369)

Event Date 08/15/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: unknown locking screw.Report source: foreign country: germany.Customer has indicated that the product will not be returned to zimmer biomet for investigation, due to the device remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

Zimmer biomet received an anonymized study report summarizing the data of the titanium universal locking system when used for long bones collected on a clinical study.It was reported that a patient experienced pseudoarthrosis and a re-operation was needed.Attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

Zimmer biomet received an anonymized study report summarizing the data of the titanium universal locking system when used for long bones collected on a clinical study with the marien hospital in germany.It was reported that a patient was revised approximately 3 years post implantation due to pseudoarthrosis.Due diligence is complete as multiple attempts were made; however, no further information is available.As no additional information or product is available, we are unable to provide further information.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: a2; a3; b1; b3; b5; d1; d2; d4; d6; g4; h6; d10: 47494600607 3.5 mm locking dual compression plate 00236901435 3.5 mm locking screw 14 mm length x2, 00236901635 3.5 mm locking screw 16 mm length x2, 00236901835 3.5 mm locking screw 18 mm length x2.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2022 - 02104 0001822565 - 2022 - 02105 0001822565 - 2022 - 02106 0001822565 - 2022 - 02107 0001822565 - 2022 - 02108.

Event Description

No further event information at time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections have been updated: b4; b5; d2; g2; g3; h2; h3; h6; h10.Visual and dimensional evaluations of the product could not be performed as no product was returned nor were pictures provided.Device history record review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined.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.H3 other text : see h10 narrative.

• Brand Name: 3.5 MM LOCKING DUAL COMPRESSION PLATE 6 HOLES 79 MM LENGTH
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 14675344
• MDR Text Key: 293911256
• Report Number: 0001822565-2022-01762
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K082527
• 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: 09/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 47494600607
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/21/2022
• 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
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE; SEE H10 NARRATIVE
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 37 YR
• Patient Sex: Female