MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. SHELL 44 MM O.D.; PROSTHESIS, HIP

Model Number N/A

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Joint Dislocation (2374)

Event Date 04/25/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).Report source: foreign: (b)(6).The device will not be returned for analysis, as the device has been discarded; however, an investigation of the reported event is in progress.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported a patient underwent a revision procedure approximately two 2 weeks post implantation due to dislocation of the bipolar cup.Bipolar cup and cocr head were removed and replaced with a g7 cup.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

Radiographs were provided and reviewed by a health care professional.Review of the available records identified dislocation of the right hip arthroplasty as noted.Device history record was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to 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.

Event Description

No further event information available at the time of this report.

• Brand Name: SHELL 44 MM O.D.
• 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: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 14376228
• MDR Text Key: 291515736
• Report Number: 0002648920-2022-00121
• Device Sequence Number: 1
• Product Code: KWY
• UDI-Device Identifier: 00889024115293
• UDI-Public: (01)00889024115293(17)310315(10)65052779
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K833991
• 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: 07/25/2022

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 Model Number: N/A
• Device Catalogue Number: 00500104400
• Device Lot Number: 65052779
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/25/2022
• Initial Date FDA Received: 05/12/2022
• Supplement Dates Manufacturer Received: 07/22/2022
• Supplement Dates FDA Received: 07/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/29/2021
• 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: CAT#: 00500104428 LINER LOT#: 65142817.; CAT#: 11-300812 ARCOS STEM LOT#: 896150.; CAT#: 11-301310 ARCOS CON LOT#: 153570.; CAT#: 163660 COCR HEAD LOT#: J7006673.
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Female
• Patient Weight: 80 KG