MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMPREHENSIVE REVERSE HUMERAL TI TRAY; PROSTHESIS, HIP

Catalog Number 115340

Device Problems Fracture (1260); Separation Failure (2547); Noise, Audible (3273); Difficult or Delayed Separation (4044)

Patient Problems Pain (1994); Loss of Range of Motion (2032); Scar Tissue (2060); Limited Mobility Of The Implanted Joint (2671); Subluxation (4525)

Event Date 07/17/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Device product code: phx.Concomitant medical products: versa-dial/comp ti std taper cat# 118001 lot# 827550, comp rvrs shdr glen bsplt +ha cat# 115330 lot# 524380, comp non-lckng screw 4.75x30mm cat# 180510 lot# 905470, comp primary stem 14mm std cat# 113654 lot# 264080, comp non-lckng screw 4.75x30mm cat# 180510 lot# 468680, comp rvrs shldr glnsp std 36mm cat# 115310 lot# 258260, comp rvs cntrl scr 6.5x35mm st cat# 115383 lot# 732410, arcom xl 44-36 std hmrl brng cat# xl-115363 lot# 767690.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

Event Description

It was reported that a patient underwent left total reverse shoulder arthroplasty.Subsequently, the patient underwent a revision procedure approximately 4 years later due to pain and limited mobility, where the humeral morse taper fractured and could not be removed.An extraction tool was ordered and the patient went back to surgery 2 days later when the revision was completed.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were corrected: d11: lot#.D11: comp primary stem 14mm std cat#: 113654, lot#: 254080.Reported event was unable to be confirmed due to limited information received from the customer.Review of the device history record(s) identified no deviations or anomalies during manufacturing of tray related to the reported event.The root cause of the reported issue (tray fracture) is attributed to design deficiency.This is being addressed through the capa process.A definitive root cause cannot be determined for the post unable to extract event.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

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

Manufacturer Narrative

(b)(4) this follow-up report is being submitted to relay additional information.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

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

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of medical records.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined.Medical records and radiographs identified the following: revision surgery x-ray review identified the components remain in position and alignment, no obvious loosening.Subdeltoid adhesions were released and resected as needed.Fluid cultured, but appeared normal and deep scar tissue had titanium staining.Humeral bearing plate spun freely and was removed; his biomet prosthesis was an early version and the humeral morse taper peg had separated from the bearing plate.Stem and glenoid well-fixed with no signs of wear.Extensive attempts were made to remove the broken peg from the humeral morse taper socket but to no avail.Therefore, an attempt was made to utilize and repair the broken assembly by changing the poly and cementing the peg back to the plate, but this failed with 2 attempts.In order to use the two types of extraction tools, glenosphere removal was required.Despite numerous attempts with both tools, the peg could not be dislodged from the morse taper socket.Therefore, the humeral stem was removed as well.Review of post op x-ray: humeral component is located inferiorly, but this may be positional.Possible minimally displaced periprosthetic fracture of the medial cortex of the proximal humerus is noted.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 available at the time of this report.

• Brand Name: COMPREHENSIVE REVERSE HUMERAL TI TRAY
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9920469
• MDR Text Key: 190013348
• Report Number: 0001825034-2020-01399
• Device Sequence Number: 1
• Product Code: PHX
• Combination Product (y/n): N
• PMA/PMN Number: K080642
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2020
• Device Catalogue Number: 115340
• Device Lot Number: 367320
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SEE H10; SEE H10
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 117