MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP RVS HMRL TI TRAY 44MM; PROSTHESIS, SHOULDER

Model Number N/A

Device Problems Fracture (1260); Unstable (1667); Device Dislodged or Dislocated (2923); Noise, Audible (3273); Migration (4003)

Patient Problems Failure of Implant (1924); Pain (1994); Scar Tissue (2060); Joint Dislocation (2374); Muscle/Tendon Damage (4532); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/22/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 010000589 913220 comp rvrs 25mm bsplt ha+adptr, 115310 179550 comp rvrs shldr glnsp std 36mm, 180503 372710 comp locking screw 4.75x30mm, 180504 714180 comp locking screw 4.75x35mm, 115730 861120 compr nano hmrl pps 30mm, xl-115363 740240 arcom xl 44-36 std hmrl brng.Report source foreign: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, due to the device not being released by the patient.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported patient underwent shoulder arthroplasty.Subsequently, the patient was revised on unknown date due to implant fracture.Attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

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

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.

Event Description

It was reported the patient underwent initial right reverse total shoulder arthroplasty.The patient was doing well until experiencing an episode of intense pain without associated trauma.Subsequently, the patient underwent a revision approximately seven years post implantation to remove the broken humeral tray.During the revision, the surgeon had significant difficulty removing the broken humeral tray from the well-fixed nano component, so the whole humeral construct was replaced without further complication.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.

Event Description

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

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of medical records received.Review of the available records identified that after the initial procedure, patient regained good shoulder function with slightly limited mobility and weight-bearing capacity in daily life, asymptomatic at regular check-ups.Early postop xrays showed humerus implant position change with sintering and subsidence, but following xrays showed no further progression with stable, slightly caudally tiled humeral component.The patient was presented with stabbing pain without incident/trauma and funny, different feeling in the inner shoulder with cracking.X-ray demonstrates suspected implant fracture in the humeral tray with tilting and asymmetrical gap between the humeral tray and nano component without notching.Pseudocapsule incised, considerable amount of serosanguinous fluid drains.Slight frayed subscap repair probably due to unstable humeral tray.The fractured humeral tray was removed with significant difficulty from the well-fixed nano component; the decision was made to replace the nano with a humeral stem.Scar tissue was also removed.No signs of wear in the poly bearing, glenoid components stable, no notching.Considerable bony defect then noted, from a medical point of view requires a modular implant on the humeral side for a correct joint reconstruction.New stem cemented into place without complication.Intraop fluoro - satisfactory implant position, no notching, good stability.The device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.Root cause was 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.

• Brand Name: COMP RVS HMRL TI TRAY 44MM
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11606727
• MDR Text Key: 245940010
• Report Number: 0001825034-2021-00968
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• PMA/PMN Number: K080642
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/16/2021

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
• Device Catalogue Number: 115340
• Device Lot Number: 360450
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/24/2021
• Initial Date FDA Received: 04/02/2021
• Supplement Dates Manufacturer Received: 04/06/2021; 04/12/2021; 08/11/2021
• Supplement Dates FDA Received: 04/11/2021; 05/04/2021; 08/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 75