MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN SCREW; PROSTHESIS, TRAUMA

Catalog Number UNKNOWN SCREW

Device Problem Fracture (1260)

Patient Problems Adhesion(s) (1695); Bone Fracture(s) (1870); Failure of Implant (1924); Pain (1994); Loss of Range of Motion (2032); Scar Tissue (2060); Ambulation Difficulties (2544); Osteopenia/ Osteoporosis (2651); Swelling/ Edema (4577)

Event Date 05/16/2019

Event Type  Injury  

Event Description

It was reported that the patient underwent a revision approximately six (6) months post-implantation due to pain, swelling, and multiple fragments of the femoral shaft.During the revision major bone defect, scarring, and fracture plate and screws were noted.The plate and screws were exchanged without difficulty.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: 0001822565-2021-03530, 0001822565-2021-03531, 0001822565-2021-03532, 0001822565-2021-03533, 0001822565-2021-03534, 0001822565-2021-03535, 0001822565-2021-03536, 0001822565-2021-03538, 0001822565-2021-03540.Concomitant medical devices: item# unknown femoral locking plate; lot# unknown; qty: 1; item# unknown screw; lot# unknown; qty: 8; item# unknown dall miles strapping; lot# unknown; qty: 5.Foreign - event occurred in (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product location is unknown.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.The following sections were updated/corrected: b4; b5; g3; g6; h1; h2; h3; h6 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: initial procedure on (b)(6) 2018: fell 10 days post right tka, right femur fracture fixed with plate and screws, knee components intact and stayed in.Long spiral fracture of right femur from middle 1/3 of femur to supra-condylar region.Very fragile bone.No weight bearing for 6 weeks, knee brace for 3 weeks.Visit on (b)(6) 2019: xray ¿ fracture of the screw plate in the lower 1/3 of femur.Osteosynthesis of the lower 2/3 of femur in relation to distal mutli fragment fracture of the femoral shaft.Increase edema and pain, no trauma or fever, good hip mobility, knee very limited flexion and painful, scar is good, impossible to stand or lean on.Er visit ¿ right femur xray fracture of screw plate.Revision on (b)(6) 2019 op note: general anesthesia + alr, previous incision utilized, major bone defect with significant scarring fibrosis, no loosening of the total knee components, bone chips collected from the iliac crest mixed with bank tissue for bone defect in the pseudoarthritic region, plate, screw and cerclage wires used to fix fracture.No complications.No weight bearing for 2 months, knee immobilizer for 1 month.Letter on (b)(6) 2019: severe pain in right leg with pseudoarthrosis of femur.Transfused with unknown amount of red blood cells for anemia.Part and lot identification are necessary for review of device history records, neither were provided.A definitive root cause cannot be determined.Possible contributing factors to the event are anemia, osteoporosis, and fragile bones.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: UNKNOWN SCREW
• Type of Device: PROSTHESIS, TRAUMA
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 12975005
• MDR Text Key: 282041939
• Report Number: 0001822565-2021-03537
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN 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: 03/17/2022
• 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: NI
• Patient Sequence Number: 1
• Treatment: SEE NARRATIVE IN H10
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 88 YR
• Patient Sex: Female
• Patient Weight: 50 KG