MAUDE Adverse Event Report: ZIMMER, INC. ZIMMER TM REVERSE HUMERAL STEM 14 MM STEM DIAMETER 130 MM STEM LENGTH; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Material Protrusion/Extrusion (2979)

Patient Problem No Information (3190)

Event Date 05/16/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).The customer has indicated that the device is in the process of being returned to zimmer biomet (b)(4) for evaluation.A supplemental medwatch 3500a will be submitted upon receipt of additional information.

Event Description

It was reported that during a reverse shoulder arthroplasty, it was noticed that there was a burr on the connection of the poly liner.The implant was immediately removed and another package was opened to complete the procedure.Attempts to obtain additional information are in progress however further information is not available at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.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

(b)(4).The reported event is confirmed.Products were returned; the visual inspection of the returned product exhibited gouges on the side of the boss feature.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.Review of the complaint history determined that no further action is required.It was reported that the surgeon had impacted the stem, hence it is unknown if the damage is due to manufacturing issue or was due to impacting.A definitive root cause cannot be determined with the information provided.Findings of the investigation were relayed to the complainant.No corrective actions, preventive actions, or field actions resulted after investigation of this event.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.

• Brand Name: ZIMMER TM REVERSE HUMERAL STEM 14 MM STEM DIAMETER 130 MM STEM LENGTH
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer (Section G): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6664315
• MDR Text Key: 78307142
• Report Number: 0001822565-2017-04415
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: PK052906
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/27/2018

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: 00434901413
• Device Lot Number: 63257370
• Other Device ID Number: (01)00889024268975
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/24/2017
• Initial Date FDA Received: 06/23/2017
• Supplement Dates Manufacturer Received: 09/14/2017; 02/27/2018
• Supplement Dates FDA Received: 10/13/2017; 03/02/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/25/2016
• 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
• Patient Outcome(s): Required Intervention