MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP PRIMARY STEM 6MM STD; PROSTHESIS, EXTREMITIES

Catalog Number 113646

Device Problems Loss of Osseointegration (2408); Patient Device Interaction Problem (4001); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Pain (1994); Loss of Range of Motion (2032); Muscle/Tendon Damage (4532)

Event Date 08/25/2010

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2020-01585; 0001825034-2020-01586; 0001825034-2020-01589.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.If any further information which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

It was reported patient underwent right biomet comprehensive reverse shoulder system approximately ten (10) years ago.Patient underwent a revision procedure approximately three (3)months post-implantation due to pain, loss of range of motion and loosening.

Manufacturer Narrative

No product was returned or pictures provided; visual and dimensional evaluations could not be performed.The reported products were reviewed for compatibility with no issues noted.Medical records were not provided.Dhr was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause cannot be determined.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.

Event Description

It was reported that the patient underwent a revision surgery approximately three (3) months post-implantation due to experiencing pain, loss of rom, and loosening of components.It was also noted that the patient was revised to a hemiarthroplasty due to anterior instability and loss of subscapularis.Attempts have been made and no further information has been provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.D10: item# 113851; lot# 616490 item# 118001; lot# 380310 item# 113044; lot# 817890 item# 00111314001; lot# 68234202 item# 00111314001; lot# 69524228 item# 00111314001; lot# 69524228.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 6MM STD
• Type of Device: PROSTHESIS, EXTREMITIES
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 9943719
• MDR Text Key: 190951672
• Report Number: 0001825034-2020-01588
• Device Sequence Number: 1
• Product Code: MBF
• UDI-Device Identifier: 00887868267901
• UDI-Public: (01)00887868267901
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060692
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2020
• Device Catalogue Number: 113646
• Device Lot Number: 453180
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/07/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/02/2010
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: NI
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female