MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 22.2MM DIA COCR MOD HD STD NK; PROSTHESIS, HIP

Model Number N/A

Device Problems Migration or Expulsion of Device (1395); Unstable (1667); Noise, Audible (3273)

Patient Problem Pain (1994)

Event Date 03/27/2018

Event Type  Injury  

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Concomitant medical products: cocr head pn: 163651 ln: 477330.Reported event was unable to be confirmed.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.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 has undergone three hip revision surgeries.Patient continues experience click sounds and pain.Attempts have been made to obtain additional information; however, no information is available at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.

Event Description

It was reported patient is experiencing a clicking sound and pain post revision.Tests showed patient had fluid which was drained.Patient also reported her hip caught and she fell down.Patient is also experiencing numbness in the toes.Revision is being planned yet none has been reported to date.No further information has been made available at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.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.

Manufacturer Narrative

This report is being submitted to relay additional information.The following sections have been updated.Review of the additional information received indicated no change to previously submitted investigation results.

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.

Event Description

It was reported patient is experiencing a clicking sound and pain post revision.Tests showed patient had fluid which was drained.Patient is also experiencing numbness in the toes.No further information has been made available at this time.

Manufacturer Narrative

Migration of device did not occur.Concomitant medical products: item # 162252, femoral stem, lot # 413490.

Event Description

It was reported that a patient underwent a revision surgery due to instability, clicking sound, and pain.Attempts have been made, and no further information has been provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of the provided op notes.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.It is reported that a non-zimmer biomet cup, liner was used with the biomet head.Zimmer-biomet has not confirmed the compatibility of this combination of devices, and this would be considered an off-label use of this product.However, it cannot be confirmed that this incompatibility has any definitive relationship to the reported event.A summary of the investigation was sent to the complainant conveying proper surgical technique and use of the device.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.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.

Event Description

It was reported patient was revised due to instability and a loose liner two years post implantation.Attempts to obtain additional information have been made; however, no more is available.

• Brand Name: 22.2MM DIA COCR MOD HD STD NK
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7103072
• MDR Text Key: 94351759
• Report Number: 0001825034-2017-11037
• Device Sequence Number: 1
• Product Code: KMC
• Combination Product (y/n): N
• PMA/PMN Number: PK853259
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor,health p
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 12/14/2018

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: Physician
• Device Model Number: N/A
• Device Catalogue Number: 163651
• Device Lot Number: 477330
• Other Device ID Number: (01) 00880304256446
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/08/2017
• Initial Date FDA Received: 12/10/2017
• Supplement Dates Manufacturer Received: 12/19/2017; 12/19/2017; 03/02/2018; 05/04/2018; 06/14/2018; 07/02/2018; 12/10/2018
• Supplement Dates FDA Received: 12/19/2017; 02/26/2018; 03/27/2018; 05/29/2018; 06/14/2018; 08/10/2018; 12/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 56 YR
• Patient Weight: 100