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

Model Number N/A

Device Problem Fracture (1260)

Patient Problems Adhesion(s) (1695); Failure of Implant (1924); Pain (1994); Loss of Range of Motion (2032); Synovitis (2094); Joint Dislocation (2374); Osteolysis (2377)

Event Date 10/13/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).(udi): n/a medical product: catalog #: 118801, versadial comp ti std ta per adaptor, lot # 910150 catalog #: 118801, versadial comp ti std ta per adaptor, lot # 089750.Catalog #: 180501, comp locking screw 4.75x20mm, lot # 609520.Catalog #: 180502, comp locking screw 4.75x25mm, lot # 696450.Catalog #: 180500, comp locking screw 4.75x15mm, lot # 919320.Catalog #: 180509, comp non-lckng screw 4.75x25mm, lot # 552660.Catalog #: xl-115363, arcom xl 44-36 std hmrl brng, lot # 692320.Catalog #: 115310, comp rvrs shldr glnsp std 36mm, lot # 081870.Catalog #: 115330, comp rvrs shdr glen bsplt +ha, lot # 283300.The customer has not indicated whether the product will be returned to zimmer biomet for investigation or not.Once this information is obtained a follow-up mdr will be submitted.

Event Description

It was reported that the patient underwent a shoulder arthroplasty approximately 9 years ago.Subsequently the patient underwent a revision procedure approximately 6 years post-implantation due to loss of mobility, function, and severe pain in the left shoulder and was diagnosed with a trunnion fracture off of the humeral tray.

Manufacturer Narrative

(b)(4).Reported event was unable to be confirmed due to limited information received from the customer.Device history record was reviewed and no discrepancies relevant to the reported event were found.Root cause related to design deficiency.Design enhancements were made to increase strength of the device.This event was farther investigated through the capa process.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.

Event Description

It was reported that the patient underwent a shoulder arthroplasty approximately 12 years ago.Subsequently the patient underwent a revision procedure approximately 10 years post-implantation due to loss of mobility, function, and severe pain in the left shoulder and was diagnosed with a trunnion fracture off of the humeral tray.It was further reported the patient was again revised approximately 4 years ago due to pain, dislocation, and limited mobility.During the revision, osteolysis was noted as well as a fracture of the trunnion from the humeral tray.The tray and bearing were replaced without complication.

Manufacturer Narrative

(b)(4) 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

(b)(4).Reported event was confirmed from the medical records provided which stated that the patient has little strength in their left shoulder and range of motion only at the left elbow and that shoulder dislocates with movement.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.

• 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: 10344150
• MDR Text Key: 201031347
• Report Number: 0001825034-2020-02990
• 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: consumer,other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2020
• 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 Model Number: N/A
• Device Catalogue Number: 115340
• Device Lot Number: 492450
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: ZFA 2016-26
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 95