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

Model Number N/A

Device Problem Migration (4003)

Patient Problems Necrosis (1971); Osteopenia/ Osteoporosis (2651); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/13/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant products: universal locking system titanium plate.Report source: foreign country: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, due to the device remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

Zimmer biomet received an anonymized study report summarizing the data of the titanium universal locking system when used for long bones collected on a clinical study.It was reported that a screw was removed due to a migrated intraarticular screw after bone union.Attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

Zimmer biomet received an anonymized study report summarizing the data of the titanium universal locking system when used for long bones collected on a clinical study.It was reported that a screw was removed approximately 5 months post implantation due to a migrated intraarticular screw after bone union.Due diligence is complete as multiple attempts were made; however, no further information is available.As no additional information or product is available, we are unable to provide further information.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.D4: 8 screws were implanted during the initial procedure.It is unknown which screw migrated and was removed.The migrated screw is one of the following part numbers: 00236901635 3.5 mm locking screw 16 mm length; 00236902035 3.5 mm locking screw 20 mm length x2; 00236903235 3.5 mm locking screw 32 mm length; 00236903435 3.5 mm locking screw 34 mm length; 00236904035 3.5 mm locking screw 40 mm length; 00236904835 3.5 mm locking screw 48 mm length; 00493505001 3.5 mm cortical screw self-tapping 50 mm length.D10: 47494600303 locking one-third tubular plate 3 holes 42 mm length.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Visual and dimensional evaluations of the product could not be performed as no product was returned nor were pictures provided.Device history record review was unable to be performed as the lot number of the device involved in the event is unknown.Although osteoporosis or a necrosis of the bone was listed as a possible contributing factor, medical records were not provided.Therefore a definitive root cause is unable to be determined.If any further information is found 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 at time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections have been updated: b4; b5; d2; g3; h2; h10.D4: 8 screws were implanted during the initial procedure.It is unknown which screw migrated and was removed.The migrated screw is one of the following part numbers: 47236901635 3.5 mm locking screw 16 mm length.47236902035 3.5 mm locking screw 20 mm length x2.47236903235 3.5 mm locking screw 32 mm length.47236903435 3.5 mm locking screw 34 mm length.47236904035 3.5 mm locking screw 40 mm length.47236904835 3.5 mm locking screw 48 mm length.47493505001 3.5 mm cortical screw self-tapping 50 mm length.Additional information provided does not alter previously reported investigation results.If any further information is found 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 at time of this report.

• Brand Name: SCREW
• Type of Device: SCREW, 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: 14675324
• MDR Text Key: 293912716
• Report Number: 0001822565-2022-01764
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K082527
• 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
• Report Date: 09/22/2022

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 Model Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/18/2022
• Initial Date FDA Received: 06/13/2022
• Supplement Dates Manufacturer Received: 07/04/2022; 08/10/2022; 09/15/2022
• Supplement Dates FDA Received: 07/06/2022; 09/06/2022; 09/27/2022
• 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): Required Intervention; Hospitalization
• Patient Age: 90 YR
• Patient Sex: Female