MAUDE Adverse Event Report: ZIMMER BIOMET, INC. LINER STANDARD 3.5 MM OFFSET 36 MM; PROSTHESIS, HIP

Model Number N/A

Device Problems Naturally Worn (2988); Unintended Movement (3026)

Patient Problems Pain (1994); Scar Tissue (2060); Tissue Damage (2104); No Code Available (3191)

Event Date 05/23/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: catalog number: 00801803602 lot number:62435635 brand name: cocr heads.Catalog number: 00771101100 lot number: 62449949 brand name: m/l taper stem.Catalog number: 00620005622 lot number: 62418072 brand name: acetabular cup.Catalog number: 00625006530 lot number: 62460730 brand name: bone screw.Catalog number: 00625006525 lot number:62483013 brand name: bone screw.Multiple mdr reports were filed for this event, please see associated reports: 0002648920-2020-00295, 0001822565-2020-02017.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the patient was revised due to pain, necrosis, tissue damage, elevated metal ion, impingement and implant wear approximately 4 years post implantation.Attempts have been made and additional information on the reported event is unavailable.

Event Description

It was reported that the patient was revised due to pain, necrosis, tissue damage, elevated metal ion, impingement and implant wear approximately four years post implantation.During the procedure, white caseating material (form of necrosis w/damaged tissue leaving appearance of soft cheesy substance), and scar tissue was observed in the joint space.The trunnion was worn with a small amount of visible metal wear.Small amount of impingement was noted at the 3 p.M.Position.The poly liner exhibited wear of approximately 1mm depth.The head and liner were replaced with new zimmer biomet products.No other complications/ findings related to the reported event were noted.Attempts have been made and additional information on the reported event is unavailable.

Manufacturer Narrative

This follow-up is being submitted to relay additional information.Updated: b4, b5, g4, g7, h1, h2, h3, h6, and h10.No product was returned; therefore, visual and dimensional evaluations could not be performed.Medical records were provided and reviewed by a health care professional.During the procedure, white caseating material (form of necrosis w/damaged tissue leaving appearance of soft cheesy substance), and scar tissue was observed in the joint space.The trunnion was worn with a small amount of visible metal wear.Small amount of impingement was noted at the 3 p.M.Position.The poly liner exhibited wear of approximately 1mm depth.The head and liner were replaced with new zimmer biomet products.No other complications/ findings related to the reported event were noted.Device history record (dhr) was reviewed for deviations and/ or anomalies with no related deviations / anomalies identified.A definitive root cause cannot 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 3.5 MM OFFSET 36 MM
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10128796
• MDR Text Key: 194341021
• Report Number: 0001822565-2020-02018
• 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: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 09/03/2020

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: 05/31/2018
• Device Model Number: N/A
• Device Catalogue Number: 00630505636
• Device Lot Number: 62364935
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/15/2020
• Initial Date FDA Received: 06/08/2020
• Supplement Dates Manufacturer Received: 08/28/2020
• Supplement Dates FDA Received: 09/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Hospitalization; Required Intervention