MAUDE Adverse Event Report: ZIMMER BIOMET, INC. MODULAR HUMERAL STEM 10 MM STEM DIAMETER 130 MM STEM LENGTH; PROSTHESIS SHOULDER

Model Number N/A

Device Problem Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/24/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).(udi): n/a.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.Will be returned.

Event Description

It was reported that during total shoulder procedure the stem was protruding through the packaging.Surgeon used larger size to complete the procedure.Attempts have been made and there is no additional information available at this time.

Manufacturer Narrative

(b)(4).Reported event was confirmed via the visual evaluation of the returned product which confirmed that the stem implant has poked through both the inner and outer cavities.Sterility was compromised.The corners of the carton box are slightly deformed and creased.Device history record was reviewed and no discrepancies relevant to the reported event were found.The root cause of the reported issue is attributed to transit damage.This event was farther investigated through the capa process.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: MODULAR HUMERAL STEM 10 MM STEM DIAMETER 130 MM STEM LENGTH
• Type of Device: PROSTHESIS SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10476384
• MDR Text Key: 207343914
• Report Number: 0001822565-2020-03082
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• PMA/PMN Number: K982981
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 11/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2023
• Device Model Number: N/A
• Device Catalogue Number: 00430001013
• Device Lot Number: 62350157
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1