MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. SHELL 45 MM O.D.; PROSTHESIS, HIP

Model Number N/A

Device Problems Malposition of Device (2616); Device Dislodged or Dislocated (2923)

Patient Problems Scar Tissue (2060); Joint Dislocation (2374); Joint Laxity (4526)

Event Date 07/18/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, as supplemental medwatch 3500a will be submitted.Concomitant medical products: 00500104428/bipolar liner 44/45/46mm od x 28mm id/65299025.00877502803/biolox delta fem head, 28mm, +3.5mm/3090897.01.06010.001/avenir mller stem 1 standard/ 2955598.

Event Description

It was reported a patient underwent a left hemiarthroplaty on.Subsequently, the patient underwent a revision to a total hip arthroplasty due to recurring dislocations approximately 1 month later.During the procedure, mild laxity was noted to the soft tissues and scar tissue was debrided to increase internal rotation.All components except the stem were removed and replaced.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: the patient underwent a hemiarthroplasty.During a follow up, the patient had minimal pain with imaging done, where the pelvis was noted to be well positioned and appropriate length.If dislocations occurred, a revision would be considered.Since the follow up, the patient experienced reoccurring dislocations and underwent a revision.Laxity of soft tissues was found and scar tissue debrided.The shell, liner, and head were removed and replaced with total hip zimmer products and no complications were noted.Review of the device history records identified no deviations or anomalies during manufacturing.A definitive root cause cannot 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 additional event information to report at this time.

• Brand Name: SHELL 45 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: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 15267093
• MDR Text Key: 298324405
• Report Number: 0002648920-2022-00178
• Device Sequence Number: 1
• Product Code: KWY
• UDI-Device Identifier: 00889024115330
• UDI-Public: (01)00889024115330(17)320509(10)65341078
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K833991
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2022
• 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: 00500104500
• Device Lot Number: 65341078
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/27/2022
• 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 H10
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Female
• Patient Weight: 59 KG