MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TMARS REV LINER CONST 50X28; PROSTHESIS, HIP

Model Number N/A

Device Problems Migration or Expulsion of Device (1395); Device Dislodged or Dislocated (2923)

Patient Problem Joint Dislocation (2374)

Event Date 06/03/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: item #: unknown, hip-trilogy cups-cups-unk (52mm), lot#: unknown.(b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it was discarded by hospital.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 on unknown date.Subsequently, patient was revised due to instability/dislocation.Attempts have been made to obtain further information; however, none is available.

Manufacturer Narrative

Upon receipt of additional information, it has been determined that this device did not cause or contribute to the reported event.The initial report was forwarded in error and should be voided.

• Brand Name: TMARS REV LINER CONST 50X28
• Type of Device: PROSTHESIS, HIP
• 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: 7638358
• MDR Text Key: 112346493
• Report Number: 0001822565-2018-03204
• Device Sequence Number: 1
• Product Code: KWZ
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: PK072121
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 09/30/2022
• Device Model Number: N/A
• Device Catalogue Number: 00711505028
• Device Lot Number: 63725030
• Other Device ID Number: (01) 00889024130241
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/12/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/03/2017
• 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