MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ALL-POLY TRI POLAR CUP 26X60MM; PROSTHESIS, HIP

Model Number N/A

Device Problems Unstable (1667); Device Dislodged or Dislocated (2923)

Patient Problems Joint Dislocation (2374); No Code Available (3191)

Event Date 07/19/2011

Event Type  Injury  

Manufacturer Narrative

(b)4).Date of event - manuscript was written in 2017.Concomitant products: unknown, unknown arcos distal stem, unknown.Unknown, unknown arcos proximal stem, unknown.Unknown, unknown head, unknown.Unknown, unknown liner, unknown.Unknown, unknown cup, unknown.Report source, literature - pelt, c.E.Et al (2017).Review of a modern modular femoral revision stem in revision total hip arthroplasty.Unpublished manuscript, the university of utah department of orthopaedics, salt lake city, ut.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.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.Product location unknown.

Event Description

It was reported in a journal article that three patients were revised due to instability, and revision of the stem was limited to the proximal body.Attempts have been made and additional information on the reported event is unavailable.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Concomitant medical products: 163662, 28mm mod hd std neck tp1 taper, 063130; 11-301351, arcos con sz a hi 80mm, 983940.

Event Description

It was reported that the patient was revised for right hip due to dislocation after stage i implantation.Attempts have been made and additional information on the reported event is unavailable.

Manufacturer Narrative

The follow up report is submitted to relay additional information received.11-301351 arcos con sz a hi 80mm 983940, 11-165202 rloc tripolar 41mmod28mmidsz26 781610, 11-300615 arcos 15x200mm prx tpr dist 956670, 163662 28mm mod hd std neck tp1 taper 063130.The complaint was confirmed based on the surgical notes and the x-ray that were provided.X-ray review shows superior dislocation.Device history records were reviewed and identified no deviations or anomalies relevant to the reported event.A definitive root cause cannot be determined with the information provided.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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2018-01133.

Event Description

It was reported that the patient had a dislocation and closed reduction two months pre op.The patient was free of dislocation for three month with abduction brace.However, four days later, after remove the abduction brace, the patient had another dislocation and closed reduction.Now the patient was revised due to recurring dislocations and instability.No additional information is available.

• Brand Name: ALL-POLY TRI POLAR CUP 26X60MM
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7150931
• MDR Text Key: 95924639
• Report Number: 0001825034-2017-11431
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• PMA/PMN Number: PK991990
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Type of Report: Initial,Followup,Followup
• Report Date: 05/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 05/31/2012
• Device Model Number: N/A
• Device Catalogue Number: 11-165112
• Device Lot Number: 627910
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 75 YR
• Patient Weight: 88