MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. LINER STANDARD 3.5 MM OFFSET 36 MM I.D. FOR USE WITH 50/52/54 MM O.D. SHELLS; PROSTHESIS, HIP

Catalog Number 00630505036

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Failure of Implant (1924); Necrosis (1971); Joint Dislocation (2374); Ambulation Difficulties (2544)

Event Date 12/23/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2023-00061; 0002648920-2023-00149.Cat #: 00771100720 / femoral stem 12/14 neck taper plasma sprayed press-fit cementless size 7.5 extended offset / lot #: 61171199; cat #: 00801803602 / femoral head sterile product do not resterilize 12/14 taper / lot #: 61401792 the device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

Event Description

It was reported that a patient underwent a right hip revision approximately nine years post implantation due to chronic instability.During the procedure, it was confirmed that the patients hip joint easily dislocated.There was also extensive necrotic bone and tissue that required debulking and debridement.Fluid accumulation, corrosion, muscle damage and a large pseudotumor were found.The head and liner were removed and replaced without further complication.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: the device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

Event Description

No additional event information to report at this time.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Dhr was reviewed and no discrepancies related to the reported event were found.This complaint is confirmed based on the provided medical records.Root cause is unchanged.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.

Event Description

No additional event information to report at this time.

• Brand Name: LINER STANDARD 3.5 MM OFFSET 36 MM I.D. FOR USE WITH 50/52/54 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: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 17271715
• MDR Text Key: 318511897
• Report Number: 0002648920-2023-00150
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K002960
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 08/10/2023

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: 12/31/2014
• Device Catalogue Number: 00630505036
• Device Lot Number: 61354997
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/16/2022
• Initial Date FDA Received: 07/06/2023
• Supplement Dates Manufacturer Received: 07/12/2023; 08/03/2023
• Supplement Dates FDA Received: 07/12/2023; 08/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/31/2009
• 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): Hospitalization; Required Intervention
• Patient Sex: Female