MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP RVS TRAY CO 44MM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number N/A

Device Problem Difficult to Insert (1316)

Patient Problem No Patient Involvement (2645)

Event Date 10/11/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Event occurred in (b)(6).Multiple mdrs were filed for this event.Please see associated: 0001825034-2019-04701.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Not returned to manufacturer.

Event Description

It was reported the devices were unable to be mated prior to use.No further information is available at the time of this reporting.

Event Description

No further information is available at the time of this reporting.

Manufacturer Narrative

- visual inspection if the returned product identified the bearing did not snap into the tray all the way.The loc ring is not in the correct position and a gap is identified between the two parts.- review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.- a definitive root cause cannot be determined.A possible contributing condition is the surgeon not using the recommended assembly tool.- no corrective actions, preventive actions, or field actions resulted after investigation of this event.- the complaint is confirmed.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.

Event Description

It was reported the devices were unable to be mated prior to use.The site did not use the assembly tool.No further information is available at the time of this reporting.

• Brand Name: COMP RVS TRAY CO 44MM
• Type of Device: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9203555
• MDR Text Key: 197152650
• Report Number: 0001825034-2019-04700
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 00880304543201
• UDI-Public: (01)00880304543201
• Combination Product (y/n): N
• PMA/PMN Number: K113069
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 11/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 115370
• Device Lot Number: 193790
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/11/2019
• Initial Date FDA Received: 10/17/2019
• Supplement Dates Manufacturer Received: 10/21/2019; 11/13/2019
• Supplement Dates FDA Received: 10/29/2019; 11/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: XL-115363 STD HMRL BRNG LOT 566640
• Patient Age: 75 YR
• Patient Weight: 84