MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP PRIMARY STEM 4MM MINI; PROSTHESIS, EXTREMITIES

Catalog Number 113624

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: item# 115370; lot# 716070.Item# 405800; lot# 350470.Item# 115310; lot# 365970.Item# 115399; lot# 932800.Item# 180551; lot# 118100.Item# 180554; lot# 967250.Item# 180555; lot# 869040.Item# 180556; lot# 541880.Item# 180556; lot# 723040.Item# pm555390; lot# 207310.Item# pm700312; lot# 192070.Item# pm700313; lot# 192090.Foreign report source: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.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

It was reported patient underwent shoulder arthroplasty approximately three (3) years ago.Subsequently, the patient is being considered for a revision due to loosening.Surgeon is planning on just revising the stem to a longer stem.No surgery has been scheduled to date.Attempts have been made and no further information has been provided.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.  the following sections were  updated: b4, b5, g4, g7, h1, h2, h3, h6, h10.Reported event was unable to be confirmed due to limited information received from the customer.Review of the device history records identified no deviations or anomalies during manufacturing.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not 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.

• Brand Name: COMP PRIMARY STEM 4MM MINI
• Type of Device: PROSTHESIS, EXTREMITIES
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10683717
• MDR Text Key: 211523928
• Report Number: 0001825034-2020-03810
• Device Sequence Number: 1
• Product Code: MBF
• UDI-Device Identifier: 00887868267710
• UDI-Public: (01)00887868267710
• Combination Product (y/n): N
• PMA/PMN Number: K060692
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 113624
• Device Lot Number: 493740
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: NI
• Patient Sequence Number: 1
• Treatment: SEE NARRATIVE IN H10
• Patient Outcome(s): Other
• Patient Age: 62 YR
• Patient Weight: 75