MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. SHELL POROUS WITH CLUSTER HOLES 50 MM O.D.; PROSTHETIC, HIP

Model Number N/A

Device Problem Material Erosion (1214)

Patient Problems Pain (1994); Metal Related Pathology (4530)

Event Date 10/18/2023

Event Type  Injury  

Event Description

It was reported that the patient underwent a revision procedure 6 years and 9 months post implantation due to the liner fracturing at the locking ring.There was metal transfer onto the ceramic femoral head and evidence that the head had been rubbing on the interior of the acetabular shell.Ambulation was limited by pain.There is no additional information available at the time of this report.

Manufacturer Narrative

(b)(4).D10:00630505036 item name liner standard 3.5 mm offset 36 mm i.D.For use with 50/52/54 mm o.D.Shells lot # 63353645.00877503602 item name bioloxâ® delta, ceramic femoral head, m, 㸠36/0, taper 12/14 lot # 2844194.Multiple mdr reports were filed for this event, please see associated reports 0001822565 - 2023 - 03621, 0009613350-2023-00696.The device will not be returned for analysis as it¿s location is not known; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted h3 other text : device location is unknown.

Manufacturer Narrative

Upon reassessment of the reported event, it was determined to be not reportable as there was no allegation against the device.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 as there was no allegation against the device.The initial report was forwarded in error and should be voided.

• Brand Name: SHELL POROUS WITH CLUSTER HOLES 50 MM O.D.
• Type of Device: PROSTHETIC, 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: 18345756
• MDR Text Key: 330729564
• Report Number: 0002648920-2023-00311
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 00889024118065
• UDI-Public: (01)00889024118065(17)260228(10)63283875
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K934765
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/13/2024

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: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 00620005022
• Device Lot Number: 63283875
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/24/2023
• Initial Date FDA Received: 12/18/2023
• Supplement Dates Manufacturer Received: 03/13/2024
• Supplement Dates FDA Received: 03/18/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/28/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: PLEASE SEE H10.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 76 YR
• Patient Sex: Female
• Patient Weight: 72 KG