MAUDE Adverse Event Report: ZIMMER BIOMET, INC. LINER STANDARD 3.5 MM OFFSET 40 MM I.D. FOR USE WITH 66 MM O.D. SHELL; PROSTHESIS, HIP

Model Number N/A

Device Problem No Apparent Adverse Event (3189)

Patient Problem Hematoma (1884)

Event Date 02/13/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 00620206622 shell porous with cluster holes 66 mm 62952684, 00801804005 femoral head sterile product do not resterilize 12/14 taper 62559953, unknown, unknown stem, unknown, 00625006530 bone screw 6.5x30 self-tap 63523403, 00625006525 bone screw 6.5x25 self-tap 63542109, 00625006520 bone screw 6.5x20 self-tap 62483526.Reported event was able to be confirmed from the follow up notes that were provided.Device history record was reviewed and no deviations/anomalies relevant to the reported event were found.Review of complaint history determined that no further action is required as no trends were identified.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not 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: 0001822565-2018-01737, 0001822565-2018-01740, 0001822565-2018-01741.

Event Description

It was reported that the patient is experiencing hematoma and pain after left total hip arthroplasty revision surgery.Attempts to obtain additional information have been made; however, no more is available.

• Brand Name: LINER STANDARD 3.5 MM OFFSET 40 MM I.D. FOR USE WITH 66 MM O.D. SHELL
• 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: 7365822
• MDR Text Key: 103315662
• Report Number: 0001822565-2018-01739
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK003478
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 05/31/2020
• Device Model Number: N/A
• Device Catalogue Number: 00630506640
• Device Lot Number: 62932211
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/22/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/04/2015
• 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): Other
• Patient Age: 61 YR
• Patient Weight: 104