MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNK ZPLP HUMERAL PLATE; PLATE, FIXATION, BONE

Catalog Number UNK ZPLP HUMERAL PLATE

Device Problem Migration (4003)

Patient Problems Failure of Implant (1924); Pain (1994); Discomfort (2330); Osteopenia/ Osteoporosis (2651); Skin Inflammation/ Irritation (4545)

Event Date 08/28/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).D4: full catalog number - unk zplp proximal lateral humeral plate.E1: full establishment name - royal cornwall hospitals nhs trust.G2: foreign - event occurred in the uk.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product was discarded.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 that a patient was part of a retrospective clinical study and received a zplp proximal lateral humeral plate for a bone fracture.Subsequently, the patient was experiencing pain and irritation approximately one (1) year and four (4) months post-implantation.During a consultation at the clinic, the metalwork was discovered to be prominent and the patient underwent a revision approximately one (1) month later to remove the device.Attempts have been made and no further information has been provided.

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.The following sections were updated/corrected: item# unknown screw; lot# unknown; qty: 10.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.

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.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2023-03527.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: (b)(6) 2018, office visit: x-ray: fracture healed but the metal work is fairly prominent.Patient considering having plate removed.(b)(6) 2019, office visit: no pain, good rom, obvious metal prominence.X-ray: healed fracture, metalwork prominent, questioning one screw backing out.Suggested taking plate out.(b)(6) 2019, op report: removal of metalwork from the left humerus.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: comminuted and displaced fracture of the proximal left humerus with subsequent plate and screw fixation.Stable appearance of the plate and screws on follow-up imaging.Implant fit and alignment are maintained on all images.Bone quality is osteopenic and stable.One of the proximal screws extends slightly beyond the cortical articular surface of the humeral head and is thus slightly long.This screw protrudes into the glenohumeral space on all of the images dated (b)(6) 2018 through (b)(6) 2019.Part and lot identification are necessary for review of device history records, neither were provided.It was noted one screw was protruding in to the glenohumeral space from the time of implantation.However, this is left up to surgeon's discretion.With the provided information, it cannot be determined if this caused or contributed to the patient's pain.As such, 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 ZPLP HUMERAL PLATE
• 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: 17407171
• MDR Text Key: 319923702
• Report Number: 0001822565-2023-02010
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K043227
• 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
• Report Date: 12/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK ZPLP HUMERAL PLATE
• 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: 12/06/2023
• 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: NI
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Weight: 61 KG