MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ABSOLUTE BI-POLAR POLYETHYLENE; PROSTHESIS, SHOULDER

Catalog Number 113169

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fall (1848); Pain (1994); Loss of Range of Motion (2032); Limited Mobility Of The Implanted Joint (2671)

Event Date 09/29/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 52mm absolute bi-polar shell cat#113159 lot#ni.Bio-mod bipolar 22.2/std hd cat#113143 lot#ni.Comp primary stem 8mm std cat#113648 lot#ni.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2020 - 03514.0001825034 - 2020 - 03519.0001825034 - 2020 - 03520.

Event Description

It was reported that the patient underwent a right total shoulder arthroplasty approximately 4 years ago.Subsequently, patient is experiencing ongoing pain, minimum range of motion, difficulty in normal home activities such as: sweeping, mopping, chopping, making the bed, stirring, brushing hair, writing and has to lift right arm with left hand and hold on to something.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.

Event Description

Upon review of additional medical records, it was noted that the patient has fallen on the implanted shoulder twice since implantation.

Event Description

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

Manufacturer Narrative

D11: comp primary stem 9mm mini cat#113629 lot#074970, bio-mod bipolar 22.2/+2mm hd cat#113144 lot#368690, 44mm absolute bi-polar shell cat#113153 lot#170240.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: initial surgery noted interscalene block, general anesthesia.Est.Blood loss 100 cc.Anterior exposure of shoulder.Severe glenohumeral joint osteoarthritis noted.30 degree retroversion of the neck.9mm reamer and then to a #9 broach in 30 degrees retroversion.44 glenoid and a +2 neck was found stable and satisfactory on trial.9 mm humeral component placed in 30 degrees retroversion with a 22.2 mm head placed onto the reverse morse tapered locking mechanism.Bipolar glenoid cup was assembled and shoulder reduced with excellent fit and fill as well as rom and stability.No complications noted during initial procedure.4 year post op x-ray noted humeral head prosthesis in good position.Patient stayed in hospital for 2 days due to pain.Follow up visit records noted patient letter states they have been in pain, minimum range of motion, difficult to do normal activities.1 month post op x-ray shows satisfactory right tsa placement.Pt continues to have pain which would be expected at this time postoperatively.Patient had percocet prescription renewed.Pt continued.3 months post op noted patient feels shoulder is a slow recovery.Still has stiffness, swelling pain and decreased rom.X-ray still shows good alignment.Reflexes normal.Forward flexion 100 degrees and abduction 100 degrees and normal.No atrophy noted.Percocet renewed again and pt continued.4 months post op noted well healed incision.Patient states right shoulder is improving.Assessment normal.Forward flexion 100 degrees and abduction 100 degrees.Normal rom.1 year postop patient states right shoulder is improving, having less pain however her shoulder is sore and stiff.Patient tripped over generator landing on her right shoulder five days prior following hurricane irma.Assessment appears normal.Forward flexion 130 degrees and abduction 130 degrees.X-ray shows normal findings.3.5 years postop patient followed up for pain and stiffness in right shoulder and also left hip after falling when getting out of her boat.She hit her ribs and sustained multiple left-sided rib fractures.She has had increased discomfort with her right shoulder.Pain radiates down to her right elbow, numbness in her right middle finger and has been taking ibuprofen.Assessment is normal.X-ray findings are normal.Conservative treatment.Patient declines any surgery for shoulder as it does not bother her enough.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.A definitive root cause cannot be determined.A contributing factor is the patient's history of multiple falls, however, it remains unknown what is causing the alleged issues and the failure of the devices.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: ABSOLUTE BI-POLAR POLYETHYLENE
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10548651
• MDR Text Key: 207505959
• Report Number: 0001825034-2020-03518
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• PMA/PMN Number: K030710
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup,Followup
• Report Date: 02/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2019
• Device Catalogue Number: 113169
• Device Lot Number: 983090
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 69