MAUDE Adverse Event Report: ZIMMER GMBH DURAL ALPHA INSERT NEUTR II/36; HIP IMPLANT

Model Number N/A

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Subluxation (4525)

Event Date 11/01/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).D10: allofit alloclassic shl 52/ii item # 00000004245, lot #3067706.Avenir muller stem 4 standard item # 01.06010.004, lot # 3131823.G2: foreign: australia.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 will be submitted.Multiple mdr reports were filed for this event, please see associated reports 0009613350-2023-00617.

Event Description

It was reported that the patient reported subluxation of hip.Hip was revised and femoral head was replaced with an increased offset.Due diligence is in progress for this complaint; to date no additional information or product has been received.

Event Description

No additional information at this time.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.No product was returned, or pictures provided; visual and dimensional evaluations could not be performed.A review of the device manufacturing records confirmed no abnormalities or deviations that could be related to the reported event.The reported products were reviewed for compatibility with no issues noted.Review of the complaint histories found no additional related complaints for these item/s and the reported part and lot combinations.With the available information, a definitive root cause could not be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: DURAL ALPHA INSERT NEUTR II/36
• Type of Device: HIP IMPLANT
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 18131430
• MDR Text Key: 328053638
• Report Number: 0009613350-2023-00618
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 00889024413627
• UDI-Public: (01)00889024413627(17)270203(10)3099129
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K192416
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/08/2024

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: 01.00013.709
• Device Lot Number: 3099129
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/04/2023
• Initial Date FDA Received: 11/14/2023
• Supplement Dates Manufacturer Received: 02/02/2024
• Supplement Dates FDA Received: 02/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/09/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE NARRATIVE IN H10.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female