MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CONSTRAINED LINER WITH CONSTRAINING RING; PROSTHESIS, HIP

Model Number N/A

Device Problems Material Erosion (1214); Device Dislodged or Dislocated (2923); Positioning Problem (3009); Insufficient Information (3190)

Patient Problems Unspecified Infection (1930); Pain (1994); Joint Dislocation (2374); Reaction (2414)

Event Date 06/05/2015

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.Concomitant medical products: unknown, unknown head, unknown; unknown, unknown stem, unknown; unknown, unknown cup, unknown.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2017 - 07046, 0001822565 - 2017 - 07047, 0001822565 - 2017 - 07048.Product location unknown.

Event Description

It was reported patient underwent hip revision due to infection.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Concomitant medical products: head catalog #: unk, lot#: unk, m/l taper kinectiv stem catalog#: unk, lot#: unk, cup catalog#: unk, lot#: unk, m/l taper kinectiv neck, catalog#: unk, lot#: unk.Reported event was unable to be confirmed as part number / lot number of device involved in the incident is unknown.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 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:0001822565-2017-07046, 0001822565-2017-07047, 0001822565-2017-07048, 0001822565-2017-07985.

Event Description

It was reported that the patient has undergone approximately four (4) unknown procedures and/or debridements due to continuing infection and pain, and recurrent dislocation.No further information provided.

Manufacturer Narrative

Upon reassessment of the reported event, it was determined to not be reportable as infection was greater than one year post-implantation.The initial report was submitted in error and should be voided.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Concomitant medical products: bone screw 6.5x30 self-tap catalog#: 00625006530 lot#: 62249795.Unknown screw catalog#: ni lot#: ni.M/l taper kinectiv stem size 11 catalog#: 00771301100 lot#: 62282094.Kinectiv modular neck g1 catalog#: 00784802301 lot#: 62089144.Biolox delta fem head, 36mm, +0mm catalog#: 00877503602 lot#: 27193379.Continuum cluster-hole shell, 60 mm catalog#: 00875706001 lot#: 62208327.Reported event was confirmed through review of medical records.Device history record was reviewed and no discrepancies relevant to the reported event were found.Review of the 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.

Event Description

It was reported that the patient underwent a right total hip revision surgery approximately 15 month post previous revision surgery, due to infection.During the revision, it was found that the femoral neck was impinging on the locking ring on the liner.There was erosion of the locking ring and some notching of the neck.Extensive metallosis was found.Attempts have been made and additional information on the reported event is unavailable.

• Brand Name: CONSTRAINED LINER WITH CONSTRAINING RING
• 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: 6945117
• MDR Text Key: 89261457
• Report Number: 0001822565-2017-07049
• 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: consumer,health professional
• Reporter Occupation: Patient
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 12/31/2015
• Device Model Number: N/A
• Device Catalogue Number: 00875801436
• Device Lot Number: 61596159
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/02/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/26/2011
• 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: 66 YR
• Patient Weight: 77