MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TM REVERSE GLENOSPHERE 36 MM DIAMETER; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Fall (1848); Joint Dislocation (2374)

Event Date 03/15/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant product(s): unknown glenoid.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2018 - 01221.

Event Description

It was reported that a patient underwent an initial shoulder surgery on an unknown date.Subsequently, the patient fell and dislocated.Attempts have been made and additional information on the reported event is unavailable.

Manufacturer Narrative

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

Manufacturer Narrative

This report is being submitted to relay corrected information.Upon reassessment of the reported event, it was determined to be not reportable as this component did not cause serious injury.

Manufacturer Narrative

Previous supplemental report inadvertently reported that the device did not contribute to serious injury.Upon receipt of additional information, it can not be confirmed that a patient fall led to the reported dislocation.Please disregard the previous report.Concomitant medical products: 00434906506 retentive poly liner plus (+) 6 mm offset 36 mm diameter 65 degree neck angle 63594041; 00434901013 humeral stem 10 mm stem diameter 130 mm stem length 63662474; 00434902502 base plate 25 mm post length +2 mm lateral offset uncemented 63799968; 0104223033 anatomical shoulder â?¢ reverse, screw system, 4.5-33 2857358; 0104223042 anatomical shoulder â?¢ reverse, screw system, 4.5-42 2865695; 00434903912 humeral stem spacer size 12 mm 62209083.The complaint is under investigation.Once the investigation is completed a follow mdr will be submitted.

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.No additional information is made available.

Manufacturer Narrative

The following report is being submitted to relay additional information received: udi: (b)(4).00434906506 retentive poly liner plus (+) 6 mm offset 36 mm diameter 65 degree neck angle 63594041 00434903912 humeral stem spacer size 12 mm 62209083 00434901013 humeral stem 10 mm stem diameter 130 mm stem length 63662474 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 and retractors placed at baseplate or glenosphere junction in could but could not extract the glenosphere however it was left insitu.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 - 2019 - 01996 0001822565 - 2019 - 01997.

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.

Event Description

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

Manufacturer Narrative

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

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, g4, g7, h2, h3, h6, h10 review of complaint history found no additional related issues for the glenosphere and 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: TM REVERSE GLENOSPHERE 36 MM DIAMETER
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7302297
• MDR Text Key: 101129307
• Report Number: 0001822565-2018-01220
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• PMA/PMN Number: K121543
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor,health p
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 06/09/2020

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?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 00434903611
• Device Lot Number: 63606546
• Other Device ID Number: N/A
• 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 H10 NARRATIVE; SEE NARRATIVE IN H10
• Patient Outcome(s): Hospitalization; Other
• Patient Weight: 104