MAUDE Adverse Event Report: . LINER STANDARD; PROSTHESIS, HIP

Catalog Number 00630505036

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Joint Dislocation (2374); Impaired Healing (2378)

Event Date 10/31/2019

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 location remains unknown.The investigation is in process.Once the investigation is complete, a follow ¿up mdr will be submitted.Concomitant medical product(s): item #650-1057/bioloxd hd/lot#2958840; item #650-1067/ tpr sleve/ lot# 2954556; item #11-303015/arcos body/lot # 316650; item #00223200418/ cerclage cable/ lot #64208909; item #00223200418/ cerclage cable/ lot #64208909; item #00223200418/ cerclage cable/ lot #64201775; item #00223200418/ cerclage cable/ lot # 63796066; item# 76-6016/ 5cc beta bsm kit/ lot # 102174-0211.

Event Description

It was reported patient underwent hip revision surgery approximately 7 months post implantation due to dislocation and delayed bone healing.Liner and cup were revised and cables were put in place.Attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

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

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.Dhr was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to be determined.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.

• Brand Name: LINER STANDARD
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): .; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9772583
• MDR Text Key: 191738899
• Report Number: 0001822565-2020-00748
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K002960
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 06/05/2020

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 Expiration Date: 10/31/2023
• Device Catalogue Number: 00630505036
• Device Lot Number: 64191779
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/05/2020
• Initial Date FDA Received: 02/29/2020
• Supplement Dates Manufacturer Received: 06/02/2020
• Supplement Dates FDA Received: 06/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 68