MAUDE Adverse Event Report: ZIMMER BIOMET, INC. SHELL WITH CLUSTER HOLES; PROSTHESIS, HIP

Catalog Number 00875705601

Device Problems Material Erosion (1214); Unintended Movement (3026); Noise, Audible (3273)

Patient Problems Pain (1994); Tissue Damage (2104); Patient Problem/Medical Problem (2688)

Event Date 12/04/2015

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 is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Concomitant medical products: item # 00771101520/ femoral stem neck taper/ lot # 61712783, item# 00801802814/femoral head / lot # 62542708, item # 00875801228 / liner/lot # 61675526 , item # 00625006540/bone screw /lot # 62462616, item # 00625006530 bone screw/ lot # 61911788.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 -2020 -01298, 0001822565 -2020 -01300, 0001822565 -2020 -01301.

Event Description

It was reported patient underwent hip revision surgery 4 years post implantation due to pain and squeaking.During the revision, metal debris was noted from the femoral neck impinging on the metal ring of the locking liner.The shell, head, and liner were replaced without complication, and another attempt to repair the abductors was made.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

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

Event Description

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

• Brand Name: SHELL WITH CLUSTER HOLES
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9932959
• MDR Text Key: 187164540
• Report Number: 0001822565-2020-01302
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K151448
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 06/10/2020

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: 10/31/2021
• Device Catalogue Number: 00875705601
• Device Lot Number: 61903786
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/12/2020
• Initial Date FDA Received: 04/07/2020
• Supplement Dates Manufacturer Received: 06/05/2020
• Supplement Dates FDA Received: 06/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 169