MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. LINER 22 MM I.D. FOR USE WITH 42/43 MM O.D. SHELLS; PROSTHESIS, HIP

Catalog Number 00500104222

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Joint Dislocation (2374)

Event Date 09/16/2021

Event Type  Injury  

Event Description

It was reported that patient underwent revision surgery 1-month post implantation due to dislocation.The cup and liner were revised.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation as the product was requested but was discarded by hospital.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Concomitant medical products: item# 0 00500104300/ shell/ lot # 65027835.Report source: (b)(6).Multiple mdr reports were filed for this event, please see associated reports: 0002648920-2021-00430.

Manufacturer Narrative

Upon reassessment of the reported event, it was determined that the liner did not contribute to the reported event.The initial report was forwarded in error and should be voided.

Event Description

Upon reassessment of the reported event, it was determined that the liner did not contribute to the reported event.The initial report was forwarded in error and should be voided.

• Brand Name: LINER 22 MM I.D. FOR USE WITH 42/43 MM O.D. SHELLS
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer (Section G): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 12910063
• MDR Text Key: 281527423
• Report Number: 0002648920-2021-00429
• Device Sequence Number: 1
• Product Code: KWY
• UDI-Device Identifier: 00889024115262
• UDI-Public: (01)00889024115262(17)290706(10)65029502
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K833991
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 00500104222
• Device Lot Number: 65029502
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/15/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/19/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SEE H10.
• Patient Outcome(s): Required Intervention; Hospitalization