MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP RVRS SHLDR GLNSP STD 36MM; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Loss of Range of Motion (2032); Sleep Dysfunction (2517); Ambulation Difficulties (2544)

Event Date 07/12/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4) multiple mdr reports were filed for this event.Please see associated reports: 0001825034-2018-01404, 0001825034-2018-01405, 0001825034-2018-01406, 0001825034-2018-01408.Concomitant medical products: 113631 comp primary stem 11 mm mini lot 958170, 115340 comp rvs hmrl ti tray 44 mm lot 266170, xl-115363 arcom xl 44-36 std hmrl brng lot 118220, 010000589 comp rvrs 25 mm bsplt ha+adptr lot 566470, 115381 comp rvs cntrl scr 6.5 x 25 mm st lot 424370, 180503 comp locking screw 4.75 x 30 mm lot 801940, 180504 comp locking screw 4.75 x 35 mm lot 460530, 180513 comp non-lckng screw 4.75 x 45 mm lot 402380.(b)(6).Reported event was unable to be confirmed due to limited information received from the customer.Dhr was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required as no were trends identified.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.Device remains implanted.

Event Description

It was reported in clinical study (b)(6) the patient had pain 3 years post total shoulder arthroplasty.The pain was reported at a level of 7 on a scale of 10 and the patient took non-narcotic pain medication for this.The patient was unable to sleep on the affected side, unable to wash their back, unable to lift 10 pounds above their shoulder, unable to throw a ball and unable to do sports.Attempts have been made and no further information has been made available at this time.

• Brand Name: COMP RVRS SHLDR GLNSP STD 36MM
• 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: 7295931
• MDR Text Key: 100910388
• Report Number: 0001825034-2018-01407
• Device Sequence Number: 1
• Product Code: PAO
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: PK080642
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,s
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 07/31/2023
• Device Model Number: N/A
• Device Catalogue Number: 115310
• Device Lot Number: 183450
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/12/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/02/2013
• 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: 67 YR
• Patient Weight: 61