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

Catalog Number	113624
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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 or Problem Description
No further event information available at the time of this report.
Additional 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
• Common Device Name: PROSTHESIS, EXTREMITIES
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10683717
• Report Number: 0001825034-2020-03810
• Device Sequence Number: 437228
• Product Code: MBF
• UDI-Device Identifier: 00887868267710
• UDI-Public: (01)00887868267710
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K060692
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/08/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/02/2025
• Device Catalogue Number: 113624
• Device Lot Number: 493740
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/25/2020
• Supplement Date Received by Manufacturer: 12/08/2020
• Initial Report FDA Received Date: 10/15/2020
• Supplement Report FDA Received Date: 12/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: NI
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE NARRATIVE IN H10
• Outcome Attributed to Adverse Event: Other
• Patient Age: 62 YR
• Patient Weight: 75