MAUDE Adverse Event Report: ZIMMER BIOMET, INC. MD HYBRID GLENOID BASE 4MM; SHOULDER, PROTHESIS

Catalog Number 113954

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Pain (1994); Joint Dislocation (2374); Joint Laxity (4526)

Event Type  Injury  

Event Description

It was reported that the patient is being indicated for an upcoming revision procedure due to subluxation/dislocation.During the patient's appointment ligament laxity and voluntary instability were noted.No additional patient consequences were reported.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034 -2023 -02297.Versa-dial 46x18x53 hum head cat: 113042 lot: 198030.Pt hybrid glen post regenerex cat: pt-113950 lot: 904840.Versa-dial/comp ti std taper cat: 118001 lot: 310720.Compr nano hmrl pps 36mm cat: 115736 lot: 463440.Unknown palacos cement.G2: foreign: united kingdom.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 report will be submitted.H3 other text : product not returned.

Event Description

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

Manufacturer Narrative

No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record(s) identified no deviations or anomalies during manufacturing.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: - 6-weeks post-op: patient reports mild pain being a 4 out of 10, taking pain medication ¿ this is a normal finding at 6-weeks post-op.Patient reports shoulder feels stable.No significant findings on x-ray.- 1-year post-op : patient reports a pain of 6 out of 10, taking 8 pain pills a day.Shoulder feels stable.Patient reports on a scale to 0-100 shoulder function being an 80 with 100 being normal.- 2-year post-op: patient reports pain an 8 out of 10 and takes an average of 10 pain pills a day.On physician assessment cuff atrophy is noted.No instability or ligament laxity noted.Patient reports on a scale to 0-100 shoulder function being a 60 with 100 being normal.No significant findings on x-ray.- 3-year post-op: patient reports pain of a 6 out of 10 but not taking any pain medications.Physician assessment noted no atrophy, normal strength, no instability or laxity.Patient reports on a scale to 0-100 shoulder function being a 50 with 100 being normal.Patient has been using crutches after having a right total hip replacement this has been causing some shoulder pain.No significant finding on x-ray.- , 5-year post-op: patient rates pain a 5 out of 10 and reports taking 25 pain pills per day.Also reports shoulder feel unstable about a 3 out of 10.Physician assessment voluntary instability and generalized ligamentous laxity.Patient using elbow crutches as waiting for right hip revision.Patient reports on a scale to 0-100 shoulder function being a 30 with 100 being normal.No significant findings on x-ray.- , 7-year post-op : patient reports pain of a 9 out of 10 and taking pain medications.Patient reports shoulder feels unstable about an 8 out of 10.Patient reports unable to complete adl¿s.Physician assessment no instability or laxity.Patient reports on a scale to 0-100 shoulder function being a 25 with 100 being normal.Ae; dislocation / subluxation.According to the per patient had a dislocation/subluxation, date of onset is unknown.Patient is listed for revision surgery.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: a right shoulder arthroplasty is present as well as a single separate screw entering anteriorly possibly from bone augmentation of the anterior glenoid.The humeral malaligned implant is subluxed and articulates with the glenoid anterosuperiorly.There is no fracture or dislocation.Radiolucency is noted along the humeral implant without evidence of loosening.Bone quality is osteopenic.Implant fit is maintained.No other concerns are identified.The reported event is not confirmed for dislocation; however, instability is confirmed based on the mmi review.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: MD HYBRID GLENOID BASE 4MM
• Type of Device: SHOULDER, PROTHESIS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 17876078
• MDR Text Key: 324979340
• Report Number: 0001825034-2023-02298
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 00880304462489
• UDI-Public: (01)00880304462489(17)210218(10)060700
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K193038
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/18/2021
• Device Catalogue Number: 113954
• Device Lot Number: 060700
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/13/2023
• Initial Date FDA Received: 10/05/2023
• Supplement Dates Manufacturer Received: 02/20/2024
• Supplement Dates FDA Received: 02/21/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/18/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 50 YR
• Patient Sex: Male
• Patient Weight: 85 KG