MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP RVS TRAY +5MM CO 44MM; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Migration (4003)

Patient Problems Pain (1994); Joint Dislocation (2374); Limited Mobility Of The Implanted Joint (2671)

Event Date 04/13/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Product code- phx.Udi: (b)(4).Concomitant medical products: 115320 comp rvrs shldr glnsp std 41mm 882260; 010000589 comp rvrs 25mm bsplt ha+adptr 425060; xl-115366 acrom xl 44-41 std hmrl brng 637840; 180553 comp lk scr 3.5hex 4.75x30 st 448890; 115396 comp rvs cntrl 6.5x30mm st/rst 54030; 180550 comp lk scr 3.5hex 4.75x15 st 209750; 180551 comp lk scr 3.5hex 4.75x20 st 706130; 180553 comp lk scr 3.5hex 4.75x30 st 4467890; 180554 comp lk scr 3.5hex 4.75x35 st 452510; 113672 comp primary stem 12 x 194 rev 147390; xl-115368 arcom xl 44-41 rtnv +3 hmrl br 899260.The complaint is under investigation.Once the investigation is complete a follow up report will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 -2019-01640, 0001825034 -2019-01641, 0001825034 -2019-01643.

Event Description

It was reported that the patient underwent a initial right shoulder arthroplasty and subsequently underwent a revision due to pain, loss of range of motion and loosening one month post primary implantation.No additional information is available.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.Device history record was reviewed and no discrepancies were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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

Upon receipt of additional information, it has been determined that this device did not cause or contribute to the reported event.The initial report was forwarded in error and should be voided.

Event Description

Upon receipt of additional information, it has been determined that this device did not cause or contribute to the reported event.The initial report was forwarded in error and should be voided.

• Brand Name: COMP RVS TRAY +5MM CO 44MM
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 8501295
• MDR Text Key: 141524198
• Report Number: 0001825034-2019-01642
• Device Sequence Number: 1
• Product Code: PHX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113069
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2019
• 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: 115375
• Device Lot Number: 960740
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/07/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/10/2016
• 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
• Treatment: SEE NARRATIVE IN H10
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male