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

Model Number N/A

Device Problem Difficult or Delayed Positioning (1157)

Patient Problem Tissue Damage (2104)

Event Date 09/18/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Complaint sample was evaluated and the reported event was confirmed.Bearing and ringlock with out the tray are returned for evaluation.Visual inspection showed that the bearing was damaged at the lip and slot possibly due to the bent ring lock.Device history record (dhr) was reviewed and no discrepancies were found.A definite root cause cannot be determined with the information provided.(b)(4).Concomitant medical products: ep-115393, e1 44-36 std hmrl brng, lot 536010; 010000589, comp rvrs 25mm bsplt ha+adptr, 163320; 110004347, sig glen ct gd/bone model set, 474650; 113615, comp primary stem 15mm micro, 595350; 115310, comp rvrs shldr glnsp std 36mm, 837030; 115395, comp rvs cntrl 6.5x25mm st/rst, 043200; 180550, comp lk scr 3.5hex 4.75x15 st, 426330; 180551, comp lk scr 3.5hex 4.75x20 st, 220010; 180552, comp lk scr 3.5hex 4.75x25 st, 603170; 406669, stn pn thd tip.125x2.5in 2pk, 222510; 106021, ringloc+ replacement ring sz21, 684250.Event occurred in (b)(6).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2018-09288.

Event Description

It was reported that during a primary comprehensive reverse shoulder procedure, the poly liner failed to seat into the humeral tray.Final seating did not result in the ring-lock mechanism correctly locking.The procedure was completed with a new liner.Resultant construct was tighter than ideal, and extra bone removal was required to prevent impingement.Attempts have been made and no further information has been provided.

• Brand Name: COMP RVS TRAY 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: 8311633
• MDR Text Key: 135208310
• Report Number: 0001825034-2019-00470
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K113069
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/05/2019

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: 115370
• Device Lot Number: 397550
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/18/2018
• Initial Date FDA Received: 02/06/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/06/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention