MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. SHELL 43 MM O.D.; PROSTHESIS, HIP

Catalog Number 00500104300

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Joint Dislocation (2374)

Event Date 08/27/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation as the product was requested but was discarded by hospital.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Concomitant medical products: item # 00500104222/ liner/ lot # 64836453, item# 802202202/ head / lot # 299892r, item # 00784802200/ neck/lot # 64960395, item # 00771300700/stem/ lot # 64870269.Report source: (b)(6).

Event Description

It was reported that patient underwent revision surgery 3 months post implantation due to dislocation of the bipolar cup from the natural acetabulum.Attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

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

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected.Updated: d4; g3; h2; h3; h6.Device history record (dhr) was reviewed and no discrepancies 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.

• Brand Name: SHELL 43 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: 13179156
• MDR Text Key: 283480075
• Report Number: 0002648920-2022-00004
• Device Sequence Number: 1
• Product Code: KWY
• UDI-Device Identifier: 00889024115286
• UDI-Public: (01)00889024115286(17)310419(10)64967128
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K833991
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 00500104300
• Device Lot Number: 64967128
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/03/2021
• 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): Required Intervention; Hospitalization