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

Model Number N/A

Device Problems Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Ossification (1428); Cyst(s) (1800); Unspecified Infection (1930); Necrosis (1971); Pain (1994); Loss of Range of Motion (2032); Synovitis (2094); Tissue Damage (2104); Joint Dislocation (2374); Osteolysis (2377); Limited Mobility Of The Implanted Joint (2671)

Event Date 08/26/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).The customer has indicated that the product will not be returned to zimmer biomet for investigation, as the devices remain implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Concomitant devices: trabecular metal reverse polyethylene liner, catalog #: 00434903603, lot #: 62249294; trabecular metal reverse humeral stem 14mm diameter, catalog #: 00434901413, lot #: 62151241; trabecular metal reverse base plate 25mm post length, catalog #: 00434902502, lot #: 62301785; inverse/reverse screw system, catalog #: 01.04223.042, lot #: 2564705; inverse/reverse screw system, catalog #: 01.04223.042, lot #: 2665729.This report is number 2 of 4 mdrs filed for the same patient (reference 0001822565-2017-03905 / 03908 / 03909).

Event Description

It is reported that the patient has been experiencing pain, recurrent dislocations and avascular necrosis following shoulder arthroplasty.No additional patient consequences have been reported.Additional information is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.Review of the complaint history determined that no further action(s) is/are required.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.

Event Description

It is reported that the patient has been experiencing pain, recurrent dislocations, limited range of motion, and avascular necrosis following reverse shoulder arthroplasty.Patient alleges that the poly liner is wearing out, but x-rays showed no concerns.No additional patient consequences have been reported.Additional information is unavailable at this time.

Manufacturer Narrative

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

Event Description

It is reported that the patient has been experiencing pain, recurrent dislocations, limited range of motion, and avascular necrosis following reverse shoulder arthroplasty.Patient alleges that the poly liner is wearing out, but x-rays showed no concerns.Mri shows internal debris as well as particulate synovitis.No additional patient consequences have been reported.Additional information is unavailable at this time.

Manufacturer Narrative

(b)(4).X-rays dated (b)(6) 2013 are reviewed and reports identified that there has been joint arthroplasty with essentially anatomic alignment and post operative changes.It was also noted in op-notes that the shoulder was reduced and carried through a range of motion; it was stable completing the right reverse shoulder replacement.No issues were noted.Previous investigation remains unchanged.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.

Manufacturer Narrative

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

Event Description

It is reported that the patient has been experiencing pain, recurrent dislocations, limited range of motion, and avascular necrosis following reverse shoulder arthroplasty.Patient alleges that the poly liner is wearing out, but x-rays showed no concerns.No additional patient consequences have been reported.Additional information is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Mri results were received that confirm a glenoid cyst and joint pseudocapsule fluid debris, along with a stress reaction along the glenoid and proximal humerus.Root cause remains undetermined.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

It is reported that the patient has been experiencing pain, recurrent dislocations, limited range of motion, and avascular necrosis following reverse shoulder arthroplasty.Patient alleges that the poly liner is wearing out, but x-rays showed no concerns.No additional patient consequences have been reported.Additional information is unavailable at this time.

Event Description

It was reported that a patient underwent a revision procedure approximately 8 years postimplantation due to pain, osteolysis, poly wear and debris, poor bone quality, limited rom, dislocation, necrosis and possible infection.Due to the poor bone quality of the patient and humeral fracture, only a hemi revision was possible with the glenosphere being revised.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.Poly liner plus 3 mm offset 36 mm diameter cat# 00434903603 lot# 62249294.Humeral stem 14 mm stem diameter 130 mm stem length cat# 00434901413 lot# 62151241.Base plate 25 mm post length +2 mm lateral offset cat# 00434902502 lot# 62301785.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: 0001822565-2017-03905, 0001822565-2017-03908, 0001822565-2017-03909.

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.H6: component code: mechanical (g04) - head.Review of the sterile cert indicates the device was sterilized per validated requirements.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: initial op notes and pathology report on (b)(6) 2013 noted preoperative diagnosis: right shoulder rotator cuff tear arthroplasty, failed hemiarthroplasty, biceps tendinitis and tearing with instability of biceps tendon.Previous incision utilized, encountered subdeltoid adhesions.Subscapularis was torn and incised off the anterior shoulder.Chronic tearing of supraspinatus and infraspinatus.Loose humerus hardware and suture removed.Bicep¿s sheath was transferred to pectoralis sheath.Cultures obtained from humeral canal.Labrum and biceps were excised.Drain placed.No complications.Portion of bone with fibrocartilage showing changes of degenerative osteoarthritis.The underlying marrow shows small areas of active hematopoiesis and focal osteopenia.Mri report on (b)(6) 2018 noted alignment is normal, small effusion with debris, minimal heterotopic ossification, particulate synovitis, 0.9 x 1 x 1.2 cm cyst area in the inferior glenoid (may be degenerative, erosion, or focal osteolysis), rotator cuff with no tendon retraction, mild to moderate atrophy and fatty replacement, tendon appears to attach from the lesser tuberosity and scarred to the pseudocapsule, stress reaction at the glenoid and humeral stem.No revision op notes were provided.The root cause of the reported event for possible infection was determined to be unrelated to the implanted zb devices.The root cause for the other reported issues remains unknown.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: TRABECULAR METAL REVERSE GLENOSPHERE 36MM DIAMETER
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer (Section G): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6618606
• MDR Text Key: 76869352
• Report Number: 0001822565-2017-03907
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK121543
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 08/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 01/31/2023
• Device Model Number: N/A
• Device Catalogue Number: 00434903611
• Device Lot Number: 62239886
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/14/2013
• 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
• Treatment: SEE H10 NARRATIVE.; SEE H10 NARRATIVE.; SEE H10 NARRATIVE.; SEE H10 NARRATIVE.; SEE H10 NARRATIVE.; SEE H10.
• Patient Outcome(s): Required Intervention; Other; Hospitalization
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 110 KG