MAUDE Adverse Event Report: ZIMMER BIOMET, INC. LINER STANDARD 3.5 MM OFFSET 36 MM I.D.; PROSTHESIS, HIP

Model Number N/A

Device Problems Mechanical Problem (1384); Device Dislodged or Dislocated (2923)

Patient Problems Host-Tissue Reaction (1297); Scar Tissue (2060); Tissue Damage (2104); Joint Dislocation (2374)

Event Date 07/03/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2019 - 03232.

Event Description

It was reported patient underwent right hip revision approximately 4 months post implantation due to recurrent dislocations.During the revision procedure, it was noted that the external rotators were torn from their attachment.Abundant scar tissue, pseudocapsule, and impingement were also noted.The head, neck, and liner were replaced without complication.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.Reported event was confirmed by review of medical records, op notes, and radiographs.Dhr was reviewed and no discrepancies were found.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: primary op notes dated 6 mar 2019 were reviewed and no complications were noted revision op notes dated 3 july 2019 were reviewed and identified patient was revised due to recurrent dislocations.The patient was kneeling at the edge of the bed trying to reach underneath the bed the get something when he sustained a dislocation.The external rotators were torn from their attachment on the posterior greater trochanter.There were fragments of bone embedded in the external rotators.Impingement of scar tissue noted with well-fixed femoral and acetabular components.Abundant scar tissue, pseudocapsule, and impingement noted with internal rotation.Radiographs were provided and reviewed by a health care professional.Review of the available records identified there is no subluxation or dislocation.There is no osseous coverage of the lateral aspect of the right acetabular component.There is no avulsion fracture at the external rotator insertion.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.Multiple mdrs were related to this event.Please see associated reports: 0001822565 -2019 -05092, and 0001822565 -2019 -05093.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: LINER STANDARD 3.5 MM OFFSET 36 MM I.D.
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8839480
• MDR Text Key: 152602920
• Report Number: 0001822565-2019-03231
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K002960
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 12/09/2019

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 Expiration Date: 06/30/2019
• Device Model Number: N/A
• Device Catalogue Number: 00630506236
• Device Lot Number: 62731081
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/08/2019
• Initial Date FDA Received: 07/29/2019
• Supplement Dates Manufacturer Received: 11/19/2019
• Supplement Dates FDA Received: 12/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: ZIMMER CUP CAT#00620206222 LOT#64005310.; ZIMMER HEAD CAT#00877503602 LOT#2963411.; ZIMMER NECK TAPER CAT#00784801300 LOT#63822190.; ZIMMER STEM CAT#00771101600 LOT#63633114.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 93