MAUDE Adverse Event Report: ZIMMER BIOMET, INC. HUMERAL STEM 10 MM STEM DIAMETER 130 MM STEM LENGTH; PROSTHESIS, SHOULDER

Model Number N/A

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

Patient Problem Non-union Bone Fracture (2369)

Event Date 03/15/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 00434906506 retentive poly liner plus (+) 6 mm offset 36 mm diameter 65 degree neck angle 63594041, 00434903611 glenosphere 36 mm diameter 63606546, 00434903912 humeral stem spacer size 12 mm 62209083, 00434902502 base plate 25 mm post length +2 mm lateral offset uncemented 63799968, 0104223033 anatomical shoulder reverse, screw system, 4.5-33 2857358, 0104223042 anatomical shoulder reverse, screw system, 4.5-42 2865695.The complaint was confirmed based on the operative records mentioning on physical examination of x-rays, he had dislocation of his reverse total shoulder arthroplasty.While removing the extender entire auto or humeral component came out and was removed on back table.The stem was reimplanted.Review of the device history record(s) identified no deviations or anomalies.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2018 - 01221, 0001822565 - 2018 - 01220, 0001822565 - 2019 - 01996.

Event Description

It was reported that the patient underwent an initial right reverse shoulder arthroplasty and was subsequently revised due to dislocation approximately six weeks post implantation.The autologous bone/prosthetic humeral component was removed and reimplanted, and a new spacer and polyethylene liner were implanted.Glenosphere was unable to be extracted/ released from base plate and was not revised.No additional information is made available.

Manufacturer Narrative

H10 verbiage for investigation unknown this follow-up report is being submitted to relay additional information.The following sections were updated: a4, b3, b4, b5, b6, b7 g4, g7, h2, h10 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 is available at the time of this report.

Event Description

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

Manufacturer Narrative

Review of complaint history identified additional similar complaints for the stem and no additional complaints for the reported part and lot combination.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: it is noted in op-notes from initial surgery that: patient had tremendous pain and dysfunction with pseudoparalytic shoulder.Pre-operative proximal humeral shaft nonunion with preexisting end-stage oa.Rom under anesthesia with native bone was 30 degrees forward flexion and 10 degrees external rotation.In situ tenodesis performed, entire articular surface, attached greater and lesser tuberosity and 4-5cm of proximal humerus was carefully dissected free of soft tissue.Subscapularis peeled from lesser tuberosity.Humeral osteotomy was performed in 20 degrees of retroversion.10mmx130mm humerus placed.(glenoid had no cartilage left and labrectomy performed.Glenoid version corrected to neutral, large 25mm long peg drill used to ensure stability with peripheral osteophytes removed.30mm, 25mm long-peg baseplate tapped into position with excellent fixation.33/42x4.5mm screws placed with locking caps.36mm glenosphere tapped into position.(palacos prepared and placed in proximal humeral segment with 10x130 placed into segment in 20 degrees of retroversion.Orif of humerus performed with a 8-12mm cement restrictor placed distally.Proximal auto-prosthetic construct placed into distal shaft in 20 degrees of retroversion.Cement removed at former nonunion site to enhance healing, bone graft (auto and allo) placed.-+12mm metal extender and +6mm retentive poly liner placed.Noted to be stable through full rom and in vulnerable extension and external rotation.It is noted in follow up notes 1 week post op that: independent and likely doing more than should be but given living alone it¿s unavoidable.Overall doing well but becoming increasingly bothersome.No signs of infection, wound healing nicely, full active rom of elbow, wrist and fingers.It is noted in op-notes from revision surgery that: noted on follow-up visit patient was doing well with no issues.Noted on follow-up visit 2 weeks prior to revision noted little soreness, but otherwise doing well.However, x-rays taken noted dislocation of rtsa.No note of specific event or increased pain.No signs of infection.Poly liner removed from humeral stem.Glenosphere extractor placed but could not extract so left in situ.Removed the 12mm extender but the entire auto/humeral component came out.Removed the extender on the back table.Retained the humeral component since it had the proximal autologous bone attached to it still.Elected to cement humeral component 1cm more proud.Utologous/prosthetic construct placed in 20 degrees of retroversion.Extruded cement removed.Autologous bone was fashioned into a donut shape to fit the gap between the native humeral shaft and the bone graft at the prosthesis.Kinemed cable placed and tightened.9mm extender placed with +3mm poly liner and found to be stable throughout full rom and in vulnerable extension and external rotation.Additional information does not change the root cause of the previous investigation.A definitive root cause cannot be identified.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: HUMERAL STEM 10 MM STEM DIAMETER 130 MM STEM LENGTH
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8603542
• MDR Text Key: 144823801
• Report Number: 0001822565-2019-01997
• Device Sequence Number: 1
• Product Code: PHX
• Combination Product (y/n): N
• PMA/PMN Number: K060704
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2019
• 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: 00434901013
• Device Lot Number: 63662474
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE NARRATIVE IN HH10
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 65 YR
• Patient Weight: 104