MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CONSTRAINED LINER WITH CONSTRAINING RING 32 MM I.D. SIZE; PROSTHESIS, HIP

Model Number N/A

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Code Available (3191)

Event Date 09/29/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 00801803205 femoral head sterile product do not resterilize 12/14 taper lot # 37220400 00875705800 shell with uni-hole porous 58 mm o.D.Size ll for use with ll liners lot # 62355652 00875700001 dome hole plug single pack lot # 63131207 00786401520 femoral stem press-fit collarless 12/14 neck taper standard body extended neck offset size 15 160 mm stem length cementless lot # 61967829.Reported event was confirmed by review of the provided op notes.Device history record (dhr was reviewed and no discrepancies relevant to the reported event were found.Review of complaint history determined that no further action is required as no trends were identified.According to the operative notes the constrained liner was put in with the 2 raised poly pegs at the based on the previous experience, the surgeon reduced the head into the acetabulum and then for several hours, they tried to place the locking ring around the neck.It was not easy with the exposure the surgeon had.After numerous attempts, the locking ring was finally positioned acceptability and impacted solidly in place.There was a blood loss of 1000 ml.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.

Event Description

It was reported that patient underwent right total hip arthroplasty due to unknown reasons.During surgery, it was reported that it took several hours to place the locking ring around the neck and it was really difficult with the exposure the surgeon had.After numerous attempts, the surgeon was able to position the locking ring acceptably and impacted solidly in place.

• Brand Name: CONSTRAINED LINER WITH CONSTRAINING RING 32 MM I.D. SIZE
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 7074575
• MDR Text Key: 93449294
• Report Number: 0001822565-2017-07710
• Device Sequence Number: 1
• Product Code: KWZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK101730
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2019
• Device Model Number: N/A
• Device Catalogue Number: 00875801332
• Device Lot Number: 62846331
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/16/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/10/2014
• 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): Hospitalization; Required Intervention
• Patient Age: 64 YR
• Patient Weight: 117