MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 BONEMASTER LTD ACET SHL 46B; PROSTHESIS, HIP

Model Number N/A

Device Problem Malposition of Device (2616)

Patient Problem Joint Dislocation (2374)

Event Date 06/12/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product remains implanted.Concomitant medical reports: item number: 110003625, item name: biolox delta ceramic liner, lot #: 3396340.Item number: 650-1159, item name: biolox delta ceramic femoral head, lot #: 3493679.Item number: 51-108040, item name: taperloc femoral stem, lot #: 3608395.Foreign report source: (b)(6).This device is not cleared for distribution in the us, but is similar to a device cleared under k121874.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported patient underwent hip revision 1 day post-implantation due to recurrent dislocation and a malpositioned acetabular shell.During the procedure, the acetabular shell was repositioned.No additional information is available at this time.

Manufacturer Narrative

Medical records were reviewed and confirmed superior dislocation of the femoral head and identified a bony deformity of the left super acetabular region.No product was returned; visual and dimensional evaluations could not be performed.Device history record was reviewed and no discrepancies relevant to the reported event were found.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 report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

No additional information was reported.

• Brand Name: G7 BONEMASTER LTD ACET SHL 46B
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8803933
• MDR Text Key: 151476826
• Report Number: 0001825034-2019-03093
• Device Sequence Number: 1
• Product Code: PBI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,s
• Type of Report: Initial,Followup
• Report Date: 11/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2019
• 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: 010000700
• Device Lot Number: 6401724
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 44 YR
• Patient Weight: 82