MAUDE Adverse Event Report: ZIMMER BIOMET, INC. SCREW T15 MD 3.5X58MM NS; TRAUMA IMPLANTS

Model Number N/A

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Failure of Implant (1924); Necrosis (1971); Loss of Range of Motion (2032); Malunion of Bone (4529)

Event Date 10/21/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Age or date of birth: (b)(6) 1945.Concomitant medical products - medical product: catalog #: 110030401, prx hum hi plt rt 4h 90mm, lot # unknown, catalog #: 110025332, 3.2mm pegs 32mm, lot # unknown, catalog #: 110025332, 3.2mm pegs 32mm, lot # unknown, catalog #: 110025338, 3.2mm pegs 38mm, lot # unknown, catalog #: 816135034, 3.5mm cort lock scr 34mm ns, lot # unknown, catalog #: 816135048, 3.5mm cort lock scr 48mm ns, lot # unknown, catalog #: 816135052, 3.5mm cort lock scr 52mm ns, lot # unknown, catalog #: 110017724, screw t15 lp cort 3.5x24mm ns, lot # unknown, catalog #: 110017726, screw t15 lp cort 3.5x26mm ns, lot # unknown, catalog #: 110017728, screw t15 lp cort 3.5x28mm ns, lot # unknown, catalog #: 110017730, screw t15 lp cort 3.5x30mm ns, lot # unknown, catalog #: 110018050, screw t15 md 3.5x50mm ns, lot # unknown, catalog #: 110018054, screw t15 md 3.5x54mm ns, lot # unknown, catalog #: 816140030, 4.0mm canc lock scrw 30mm, lot # unknown, catalog #: 816140034, 4.0mm canc lock screw 34mm, lot # unknown, catalog #: 816140046, 4.0mm canc lock screw 46mm, lot # unknown, catalog #: 816140050, 4.0mm canc lock scrw 50mm, lot # unknown, catalog #: 816140055, 4.0mm canc lock screw 55mm, lot # unknown, report source: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.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: 0001825034-2022-02342, 0001825034-2022-02345, 0001825034-2022-02346, 0001825034-2022-02347, 0001825034-2022-02348, 0001825034-2022-02349, 0001825034-2022-02350, 0001825034-2022-02351, 0001825034-2022-02352, 0001825034-2022-02353, 0001825034-2022-02354, 0001825034-2022-02355, 0001825034-2022-02356, 0001825034-2022-02358, 0001825034-2022-02359, 0001825034-2022-02360, 0001825034-2022-02361, 0001825034-2022-02362 remains implanted.

Event Description

It was reported a patient underwent an initial right shoulder orif w/ proximal right humeral plating performed approximately 2 years ago, following a ground level fall.Subsequently, during the patient¿s one-year follow-up visit am xray imaging was completed and malunion (collapse of greater tuberosity escape) and perforation of two peg/screws was observed.The plan at that point was to reassess in 6 months.At that time the patient was referred to an orthopedic shoulder specialist for poor range of motion, osteonecrosis, and screw penetration.As of 3 months ago, the specialist has recommended arthroplasty with hardware removal which is currently pending scheduling.

Event Description

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

Manufacturer Narrative

This follow-up is being submitted to relay additional information.No product was returned, or pictures provided; therefore, visual and dimensional evaluations could not be performed.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: slight gap noted between the proximal metallic plate and the lateral cortex of the proximal humerus at the level of the greater tuberosity.Several screws at appear at the margin or extending past the margin of the glenohumeral joint space.Overall fit and alignment of the implants appears normal, although several screws appear closely approximated with the joint space.Osteonecrosis and potential for screw migration could not be confirmed.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: eighteen-month follow-up visit - moderately severe malunion (collapse of greater tuberosity escape) reassessed - very limited range of motion which has been ongoing since injury/surgery - ap and lateral x-rays performed: stable appearance of plate and screw fixation compared to previous with severe degenerative change of the glenohumeral joint consultation - diagnosis: r shoulder avascular necrosis (avn) joint orif proximal humerus junction with at least two screws penetrating joint 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 cannot be determined.If any further information is 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: SCREW T15 MD 3.5X58MM NS
• Type of Device: TRAUMA IMPLANTS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 15638589
• MDR Text Key: 302076592
• Report Number: 0001825034-2022-02357
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K083843
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2022
• 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: 110018058
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/07/2022
• 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
• Patient Outcome(s): Other
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Weight: 114 KG