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

Catalog Number UNK SCREW

Device Problem Unintended Movement (3026)

Patient Problems Failure of Implant (1924); Muscular Rigidity (1968); Pain (1994); Loss of Range of Motion (2032); Scar Tissue (2060); Osteopenia/ Osteoporosis (2651); Decreased Sensitivity (2683); Muscle/Tendon Damage (4532); Skin Inflammation/ Irritation (4545); Swelling/ Edema (4577)

Event Date 04/14/2014

Event Type  Injury  

Event Description

It was reported that a patient was part of a retrospective clinical study on zplp proximal lateral humeral plates.Subsequently, the patient was experiencing metalwork irritation, pain, crepitus, and stiffness and was revised approximately two (2) months post-implantation due to impingement by three screws.Patient later had the remaining implants removed six (6) months after the first revision due to continuation of the same problem.Attempts have been made and no further information has been provided.

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2023-02011; 0001822565-2023-02012; 0001822565-2023-02018 (plate); 0001822565-2023-02022; 0001822565-2023-02023; 0001822565-2023-02024; 0001822565-2023-02025; 0001822565-2023-02026.D10: item# unk screw; lot# unknown; item# unk screw; lot# unknown; item# unk zplp proximal lateral humeral plate; lot# unknown; item# unk screw; lot# unknown; item# unk screw; lot# unknown; item# unk screw; lot# unknown; item# unk screw; lot# unknown; item# unk screw; lot# unknown.E1: full establishment name - (b)(6).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.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.E1: contact name: ((b)(6).No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Medical records and radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: medical records - swelling, pain, and limited rom noted one month post-implantation.Device explantation two months post-implantation to remove screws impinging.Crepitus was heard prior to explantation but no longer heard after screw removal.Stiffness and limited range of motion continued to be experienced after initial explantation along with decreased sensitivity, so an additional procedure was performed to remove the remaining metalwork six months later.X-rays - right elbow olecranon fracture with plate and screw orif and anatomic alignment.Subsequent removal of 3 screws as noted without change in alignment.Implant fit and alignment are maintained on all images.Bone quality is mildly osteopenic on the initial images with worsening osteopenia on later images possibly due to disuse.No signs of loosening, impingement, wear, radiolucency or contributing factors such as malalignment that would cause issues with any of the components are identified.No implant failure or anatomic abnormality is noted radiographically.Part and lot identification are necessary for review of device history records, neither were provided.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.

Event Description

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

• Brand Name: UNK SCREW
• 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: 17413985
• MDR Text Key: 319956519
• Report Number: 0001822565-2023-02017
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K042598
• 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
• Report Date: 08/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK SCREW
• 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: 07/27/2023
• 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
• Treatment: SEE NARRATIVE IN H10.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 64 YR
• Patient Sex: Female
• Patient Weight: 52 KG