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 Pain (1994); Loss of Range of Motion (2032)

Event Date 05/25/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.(b)(4).Concomitant medical products: part # xl-115363, arcom xl 44-36 std hmrl brng, lot 640710, part # 115330, comp rvrs shdr glen bsplt +ha, lot # 319980, part # 118001, versa-dial/comp ti std taper, lot # 739270, part # 115385, comp rvs cntrl scr 6.5x45mm st, lot # part # 180502, comp locking screw 4.75x25mm, lot # 532020, part # 180511, comp non-lckng screw 4.75x35mm, lot # 852750, part # 180510, comp non-lckng screw 4.75x30mm, lot # 852660, part # 115313, comp rvsr shldr glnsp +3 36mm, lot # 179470, part # 113649, comp primary stem 9mm std, lot # 923820.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2018 - 11371.

Event Description

It was reported that approximately 7 years post implantation, the patient underwent a revision due to pain, loss of range of motion, and fracturing of the humeral tray.The humeral tray and poly liner were the only components revised.Attempts have been made and no further information has been provided.

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.Complaint was unable to be confirmed due to limited information received.No devices, photos, or medical records were received.Dhr was reviewed and no discrepancies were found.However, investigation results concluded that the reported event was due to design deficiency, as this device is in scope of a previously initiated recall due to the reported issue.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.Updated: reporter name and hospital address.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 information available at the time of this reporting.

• 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: 8184520
• MDR Text Key: 131011021
• Report Number: 0001825034-2018-11370
• 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: other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2020
• Device Model Number: N/A
• Device Catalogue Number: 115340
• Device Lot Number: 963700
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-1103-2017
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention