MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BIO-MOD HUM HEAD 44DIAX17MM; PROSTHESIS, SHOULDER

Model Number N/A

Device Problems Migration or Expulsion of Device (1395); Unstable (1667)

Patient Problem Pain (1994)

Event Date 08/31/2009

Event Type  Injury  

Manufacturer Narrative

(b)(4).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.Concomitant medical products: pt-113950, comprehensive pt hybrid glen post regenerex, 327100; 113952, comprehensive sm hybrid glenoid base 4 mm, 014740; 402433, cobalt-g hv bone cement 40 gm b, 810350; 417200, optivac kit 80 gram double mix, 503902.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2017-07498, 0001825034-2017-07499.

Event Description

It is reported that the patient previously underwent a total shoulder arthroplasty.Subsequently, the patient was revised and converted to a reverse total shoulder arthroplasty due to progressive pain, poor function, instability, rotator cuff deficiency, and loosening of the glenoid post.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

(b)(4).Concomitant medical products: pt-113950, pt hybrid glen post regenerex 327100, 113764, bio modular humeral head, 113952, comprehensive sm hybrid glenoid base 4mm, 014740, 417200, optivac kit 80gram double mix, 503902, 11-113706, bio-mod st.10x115 w/align hole 936090.The reported event is confirmed via op notes.No products were returned; therefore, the visual and dimensional inspections were not performed.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 is required.Review fo the op notes identified that there was no gross motion of the glenoid component noted.The glenoid was cut into three or four pieces and then the cement associated with the peg holes was removed.The central metallic regenerex plug was noted to be loose and clearly was not bone ingrown.A definitive root cause cannot be determined with the information provided.No corrective actions, preventive actions, or field actions resulted after investigation of this event.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: BIO-MOD HUM HEAD 44DIAX17MM
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6900433
• MDR Text Key: 87619695
• Report Number: 0001825034-2017-07500
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK030710
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 01/28/2018
• Device Model Number: N/A
• Device Catalogue Number: 113764
• Device Lot Number: 873150
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/17/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2008
• 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): Hospitalization; Required Intervention
• Patient Age: 55 YR