MAUDE Adverse Event Report: ZIMMER BIOMET, INC. DISTAL MEDIAL HUMERAL PLATE SHORT LEFT; PROSTHESIS, SHOULDER

Model Number 47-2358-008-05

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Failure of Implant (1924); Pain (1994); Non-union Bone Fracture (2369)

Event Date 10/21/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: unk zplp 3.5mm locking screws.Unk zplp 3.5mm locking screws.Unk zplp 3.5mm locking screws.Unk zplp 3.5mm locking screws.Report source: foreign- united kingdom.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device has been discarded.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: 0001822565 - 2023 - 00029, 0001822565 - 2023 - 00030, 0001822565 - 2023 - 00031, 0001822565 - 2023 - 00032.

Event Description

It was reported during a retrospective clinical study that the patient was diagnosed radiographically with a non-union.Subsequently, the patient was revised five years post initial implantation for removal of implants and a bone graft was done.No additional patient consequences were reported.

Manufacturer Narrative

(b)(4).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 further reported that the patient had a orif of the left distal humerus.Subsequently, approximately 7 years ago was revised due to increasing pain, struggle with end range extension and evidence of loosening of the proximal screws and plate, and malunion at the fracture site found on radiographic imaging.During the revision, a bone graft was placed at the malunion site and all components were removed and a new distal-medial humeral plate with k-wires was implanted.

Event Description

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

Manufacturer Narrative

(b)(4).Reported event was confirmed as review of the available records identified a orif distal humeral fracture complicated by proximal screw loosening and fracture non-union.Subsequent orif revision with subsequent plate retraction and extensive screw loosening with persistent non-union.Extensive screw loosening of both the original humeral orif and subsequent revision with fracture non-union and malalignment as described.Initial bone quality was mildly osteopenic with marked progression over time to severe osteopenia.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.A definitive root cause could not 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.

Manufacturer Narrative

(b)(4).D10 - medical product: catalog #: unknown, zplp 3.5mm locking screws, lot # unknown qty 4.Catalog #: 47235800609, distal posterior/lateral humeral plate, lot # 61208368.Catalog #: 47235901238, 3.5 mm locking screw with 2.7 mm head 12 mm length, lot # 61117349.Catalog #: 47482801202, 2.7 mm locking screw 12 mm length, lot # 60625467.Catalog #: 47482802202, 2.7 mm locking screw 22 mm length, lot # 60646645.Catalog #: 47482803802, 2.7 mm locking screw 38 mm length, lot # 61126468.Catalog #: unknown, cortical bone screw self-tapping hex head, lot # 60837245.Catalog #: 47235902438, 3.5 mm locking screw with 2.7 mm head 24 mm length, lot # unknown catalog #: unknown, unk screw, lot # unknown.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.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2023-01794 , 0001822565-2023-01795, 0001822565-2023-01796, 0001822565-2023-01797, 0001822565-2023-01798, 0001822565-2023-01799, 0001822565-2023-01800, 0001822565-2023-01894.

Event Description

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

Manufacturer Narrative

(b)(4).Device history record was reviewed and no discrepancies relevant to the reported event were found.Root cause cannot be determined based on additional information received.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: DISTAL MEDIAL HUMERAL PLATE SHORT LEFT
• Type of Device: PROSTHESIS, SHOULDER
• 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: 16102180
• MDR Text Key: 306697733
• Report Number: 0001822565-2023-00025
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K082078
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 01/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2019
• Device Model Number: 47-2358-008-05
• Device Catalogue Number: 47235810807
• Device Lot Number: 61153872
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/22/2022
• Initial Date FDA Received: 01/05/2023
• Supplement Dates Manufacturer Received: 01/30/2023; 05/02/2023; 06/15/2023; 01/19/2024
• Supplement Dates FDA Received: 02/16/2023; 05/04/2023; 07/12/2023; 01/26/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/12/2009
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 87 YR
• Patient Sex: Female
• Patient Weight: 86 KG