MAUDE Adverse Event Report: ZIMMER BIOMET, INC. E1 44-36 STD HMRL BRNG; 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).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.(b)(4).Concomitant medical products: 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; 115370, comp rvs tray co 44mm, 397550; 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).

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.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.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.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: E1 44-36 STD HMRL BRNG
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7966785
• MDR Text Key: 123748298
• Report Number: 0001825034-2018-09288
• Device Sequence Number: 1
• Product Code: PAO
• Combination Product (y/n): N
• PMA/PMN Number: PK113121
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 02/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/02/2023
• Device Model Number: N/A
• Device Catalogue Number: EP-115393
• Device Lot Number: 536010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention