MAUDE Adverse Event Report: ZIMMER BIOMET, INC. LINER ELEVATED RIM 36 MM I.D. SIZE MM; PROSTHESIS, HIP

Model Number N/A

Device Problems Unstable (1667); Malposition of Device (2616); Device Dislodged or Dislocated (2923); Unintended Movement (3026)

Patient Problems Pain (1994); Tissue Damage (2104); Joint Dislocation (2374)

Event Date 07/16/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 00801803603, femoral head sterile product do not resterilize 12/14 taper, 62806795.00784101420, por fem st 14x140 clred ext, 62547628.00875706001, continuum tm shell clust 60 mm, 62837709.00625006525,trilogy bone scr 6.5x25, 62854222.Multiple mdr reports were filed for this event, please see associated reports: 0002648920 - 2020 - 00433, 0001822565 - 2020 - 02985.Customer has indicated that the product will not be returned to zimmer biomet for investigation, product location unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported the patient underwent a left hip revision approximately 4 years post implantation due to due to pain, chronic dislocations, elevated metal ion levels, instability, tissue damage, malpositioned liner, and impingement.During the procedure the short external rotators and tissue were noted to already have been disrupted off the posterior greater trochanter.Signs of prior dislocation/instability.Attenuated tissue and disruption of the posterior capsule repair.The lipped line was noted to be placed more in an anterior position.Thus a potential source of impingement and cause of multiple dislocations of the hip.Trunnion without wear debris, fracture, or substantial deformity.No gross loosening of the stem.No gross loosening of the acetabular component.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.Reported event was confirmed via review of medical records by a health care professional.Review of the device history records for the liner identified no deviations or anomalies during manufacturing related to the reported event.Additional information does not change the outcome of the investigation.A definitive root cause cannot be determined and no corrective actions, preventive actions, or field actions resulted after investigation of this event.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 ELEVATED RIM 36 MM I.D. SIZE MM
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10605534
• MDR Text Key: 209134455
• Report Number: 0001822565-2020-03378
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• PMA/PMN Number: K200823
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 01/04/2021

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: 09/30/2019
• Device Model Number: N/A
• Device Catalogue Number: 00875201436
• Device Lot Number: 62805528
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/17/2020
• Initial Date FDA Received: 09/30/2020
• Supplement Dates Manufacturer Received: 12/30/2020
• Supplement Dates FDA Received: 01/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: NI
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 91