MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VIVACIT-E DM LINER 28 X 38MM; PROSTHESIS, HIP

Model Number N/A

Device Problems Device Markings/Labelling Problem (2911); Device Dislodged or Dislocated (2923)

Patient Problems Joint Dislocation (2374); No Code Available (3191)

Event Date 07/02/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical devices: item #: unknown, unknown head, lot #: unknown; item #: unknown, unknown stem, lot #: unknown; 110010242 g7 osseoti 3 hole shell 48mm c 6781911; 110024461 g7 dual mobility liner 38mm c 821470; 00625006515 bone scr 6.5x15 self-tap 64676690; 00625006540 bone scr 6.5x40 self-tap j6704298; 00625006520 bone scr 6.5x20 self-tap 6557304.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The product was discarded.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that patient underwent total hip arthroplasty and the surgeon indicated that immediate post-op for the case he had detected an issue of potential dislocation and thought it was a soft tissue issue.They revised the patient the same day and exchanged the bearing.The bearing implanted appears larger than the intended 38mm.No additional information is available.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Reported event was confirmed as the device has been identified as being the wrong size.Device history record (dhr) was reviewed and no discrepancies were found.The root cause of the reported issue is attributed to a manufacturing deficiency.Additional action has been initiated using corrective action process.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: VIVACIT-E DM LINER 28 X 38MM
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10456038
• MDR Text Key: 204540223
• Report Number: 0001822565-2020-03056
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 00889024572676
• UDI-Public: 00889024572676
• Combination Product (y/n): N
• PMA/PMN Number: K190656
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 09/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2020
• 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: 110031009
• Device Lot Number: 64755636
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/03/2020
• 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