MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP PRIMARY STEM 11MM MINI; PROSTHESIS - SHOULDER

Model Number N/A

Device Problem Unstable (1667)

Patient Problem Pain (1994)

Event Date 03/21/2016

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet complaint (b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2018-01561, 0001825034-2018-01562, 0001825034-2018-01563, 0001825034-2018-01564.Concomitant products: cat 115340 ¿ lot 259600 ¿ comp rvs hmrl ti tray, cat xl-115363 ¿ lot 338080 - arcom xl std hmrl brng, cat 115310 ¿ lot 480250 - comp rvrs shldr glnsp std, cat 010000589 ¿ lot 724650 - comp rvrs bsplt ha+adptr, cat 115383 ¿ lot 196620 - comp rvs cntrl scr, cat 180502 ¿ lot 961710 - comp locking screw, cat 180501 ¿ lot 165740 - comp locking screw, cat 180501 ¿ lot 458690 - comp locking screw, cat 180502 ¿ lot 340090 - comp locking screw.The product was not returned for the investigation, therefore a visual and dimensional evaluations could not be performed.Review of the device history record for pn 113631 ln 951820 identified no deviations or anomalies.This device is used for treatment.The reported components were reviewed for compatibility with no issues noted.No medical records received.Root cause could not be determined with information available.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.This report is being submitted late as it has been identified in remediation.

Event Description

(b)(6)- the patient underwent right shoulder surgery on (b)(6) 2015 and during the 6 month follow up visit it was reported that the patient experienced level 7 pain (pain score 0=no pain-10=worst pain) and difficulty performing daily activities.The patient was taking non-narcotic pain medication.Patient reported feeling that their shoulder was unstable (as if it was going to dislocate) at level 4 (0 being very stable, 10 being very unstable).Updated january 31, 2018 information from 1 year follow up visit and patient satisfaction scores are being added.During 1 year visit patient reported level 4 pain (0=no pain-10=worst pain) and difficulty performing daily activities.Patient was taking non-narcotic pain medication.No shoulder instability was reported.Patient satisfaction scores are evaluated on a scale of 1 to 10 (0= not satisfied and 10 = completely satisfied).At 6 month follow-up patient scored surgery or treatment at a 4; at one year follow-up patient scored surgery or treatment at a 3.

• Brand Name: COMP PRIMARY STEM 11MM MINI
• Type of Device: PROSTHESIS - SHOULDER
• 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: 7303742
• MDR Text Key: 101239136
• Report Number: 0001825034-2018-01560
• Device Sequence Number: 1
• Product Code: MBF
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: PK060692
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,s
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 02/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 113631
• Device Lot Number: 951820
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/21/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/05/2015
• 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): Other
• Patient Age: 59 YR
• Patient Weight: 72