MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. LINER 28 MM I.D. FOR USE WITH 50/51/52 MM O.D. SHELLS; PROSTHESIS, HIP

Model Number N/A

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Hematoma (1884); Necrosis (1971); Joint Dislocation (2374)

Event Date 12/07/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: zimmer cat# 01.06010.306 avenir stem lat cemented 6 lot# 3039253; zimmer cat# 00500105200 shell 52 mm o.D.Lot# 64892224.Report source: foreign country: (b)(6).Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2021 - 03693.

Event Description

It was reported that patient underwent a left hip arthroplasty.Subsequently, the patient was revised approximately 2.5 weeks later due to dislocation.It is believed that the original femoral component was cemented too proud.The patient hip joint was believed to be too tight.It was revised to a smaller size stem and placed with more anteversion.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

(b)(4).Concomitant medical products: zimmer cat# 01.06010.306 avenir stem lat cemented 6 lot# 3039253; zimmer cat# 00500105200 shell 52 mm o.D.Lot# 64892224.Report source: foreign country: (b)(6).Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2021 - 03693.

Event Description

It was reported that patient underwent a left hip arthroplasty.Subsequently, the patient was revised approximately 2.5 weeks later due to dislocation.It is believed that the original femoral component was cemented too proud.The patient hip joint was believed to be too tight.It was revised to a smaller size stem and placed with more anteversion.Attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

It was reported that patient underwent a left hip arthroplasty.Subsequently, the patient was revised approximately 2.5 weeks later due to recurrent dislocations.While attempting to reduce the hip, a significant abduction contracture was noted, and the patient dislocated again while in a knee immobilizer and using an abduction pillow.During the revision, a large hematoma and necrotic tissue was debrided, the posterior capsular repair was found ruptured, and the previous stem was found to have no anteversion and 3-4degrees of retroversion.A new stem was cemented into place with a new head.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.

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.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: the patient experienced recurrent dislocations.It was believed the original femoral component was cemented too proud.The previous stem had no anteversion and 3-4 degrees of retroversion.While within the joint a large hematoma and necrotic tissue was encountered.A new head and stem were implanted.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.It was mentioned that the surgeon thought the original femoral component was cemented too proud and the patient's hip joint too tight, leading to a dislocation, but this cannot be confirmed.Therefore, 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.

• Brand Name: LINER 28 MM I.D. FOR USE WITH 50/51/52 MM O.D. SHELLS
• 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: 13110858
• MDR Text Key: 285184882
• Report Number: 0002648920-2021-00461
• Device Sequence Number: 1
• Product Code: KWY
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2021
• 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: 00500105028
• Device Lot Number: 64892224
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/05/2021
• 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
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 77 YR
• Patient Sex: Male