MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 DUAL MOBILITY LINER 44MM F; PROSTHESIS, HIP

Model Number N/A

Device Problems Device Dislodged or Dislocated (2923); Difficult or Delayed Separation (4044)

Patient Problem Joint Dislocation (2374)

Event Date 06/18/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 163662 28mm mod head 753660.Xl-200150 act artic bearing 769510.010000665 g7 pps ltd acet shell 6361060.192411 echo por fmrl stem 700340.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The product location is unknown.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: 0001825034 - 2020 - 02660 head.0001825034 - 2020 - 02663 bearing.0001825034 - 2020 - 02665 shell.

Event Description

It was reported that patient underwent right hip revision (b)(6) 2020.The patient dislocated, and then disassociated due to a reduction attempt at home, on (b)(6) 2020.Patient underwent a revision on (b)(6) 2020.Liner separation failure caused 120 min delay in the procedure.Cup came out during surgery while trying to remove duel mobility liner.New cup was cemented in place.No additional information is available.

Event Description

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

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Updated: b4, b5, d4, g4, h2.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

(b)(4).This follow-up report is being submitted to relay additional information.Updated: b4, b5, d4, g4, h2, h3, h4, h6.Reported event was confirmed by review of radiographs.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to be determined.Visual inspection confirmed the shell to be assembled with the liner upon receipt.Multiple scratches were observed on the rim.Three of the scallop cut outs are gouged and deformed which corresponds to the location in which the liner is bent out of shape.A large amount of bone cement and debris is stuck to the porous coating on the outer radius of the shell.Radiographs indicate that there was a superior dislocation of a right tha.Cement fixation of the acetabular cup with prominent position of the acetabular cup because of a thick cement mantle.Possible fracture of the medial wall of the acetabulum.Heterotopic ossification along the greater trochanter was noted.Off label use could have contributed to the reported event.Porous acetabular shells and femoral stems are indicated for uncemented biological fixation.The implanted shell was found to be fixed in a cement mantle.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.

Event Description

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

• Brand Name: G7 DUAL MOBILITY LINER 44MM F
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10244927
• MDR Text Key: 197978180
• Report Number: 0001825034-2020-02666
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K150522
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup,Followup
• Report Date: 10/20/2020

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 Model Number: N/A
• Device Catalogue Number: 110024464
• Device Lot Number: 373030
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/22/2020
• Initial Date FDA Received: 07/08/2020
• Supplement Dates Manufacturer Received: 07/10/2020; 10/15/2020
• Supplement Dates FDA Received: 07/22/2020; 10/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention