MAUDE Adverse Event Report: ZIMMER BIOMET, INC. EXT-COMPREHENSIVEANATOMIC/ PRIMARY-UNK HEAD; EXTREMITY IMPLANT

Model Number N/A

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Joint Dislocation (2374); Muscle/Tendon Damage (4532)

Event Type  Injury  

Manufacturer Narrative

(b)(4).D10 - medical product: catalog #: unknown, primary liner, lot # unknown.G2: uk.H3: the customer has not indicated whether the product will be returned to zimmer biomet for investigation or not.Once this information is obtained a follow-up mdr will be submitted.Schaller g, cuthbert r, puvanendran a, ravenscroft m, sandher d, morgan b, makki d.(2022) range of movement and patient-reported outcomes in shoulder arthroplasty in the elderly: a comparison of anatomical versus reverse shoulder replacements.Cureus 14(5): e24657.Doi 10.7759/cureus.24657.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2023-01084.H3 other text : unknown if product will be returned.

Event Description

It was reported from a journal article that was retrieved from the cureus journal of medical science that reported a retrospective cohort study from the united kingdom.The purpose of the study was to assess and compare postoperative functional and range of movement outcomes between a matched patient cohort aged over 70 who had undergone total shoulder arthroplasty (tsa) and reverse tsa.The study reviewed 75 patients with 44 receiving an anatomical tsa and 31 receiving a reverse tsa.All procedures were conducted using a deltopectoral approach with a zimmer biomet comprehensive shoulder replacement.The indication for surgery was glenohumeral degenerative changes and/or rotator cuff arthropathy.The study population had a mean age of 74.1 years at time of surgery (range 70-88 years) in the tsa cohort and 76.3 years (range, 70-90 years) in the rtsa cohort.Follow-up was conducted at three months, six months, and one year postoperatively with a minimum length of follow-up of one year.The study reported two patients in the tsa cohort experienced dislocations due to subscapularis failure within the one-year follow-up period; of which, one patient was revised to a reverse total shoulder arthroplasty.

Manufacturer Narrative

(b)(4).Proposed g-code: mechanical (g04) - head.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.A definitive root cause could not be determined.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 available at the time of this report.

• Brand Name: EXT-COMPREHENSIVEANATOMIC/ PRIMARY-UNK HEAD
• Type of Device: EXTREMITY IMPLANT
• 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: 16958633
• MDR Text Key: 315534917
• Report Number: 0001825034-2023-01083
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: N/A
• Device Lot 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: 08/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Required Intervention; Hospitalization