MAUDE Adverse Event Report: BIOMET ORTHOPEDICS COMPRESS SEGMENTAL FEMORAL REPLACEMENT SYSTEM -RED SEXP DSTL FEM 18CM LT ASSY; PROSTHESIS, HIP

Catalog Number CP111827

Device Problem Collapse (1099)

Patient Problem No Information (3190)

Event Date 03/16/2017

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: item name: oss non-mod tib plate short 67, catalog number: 150417, lot number: 879630.Item name: cps xs spdl w pins 600lbf, catalog number: 178351, lot number: 454660.Item name: compress anchor plug ti 12mm, catalog number: 178402, lot number: 118150.Item name: compress cocr nut, catalog number: 178512, lot number: 599470.Item name: cps centering sleeve 15mm, catalog number: 178537, lot number: 318820.Item name: oss tib poly bearing 12, catalog number: 150410, lot number: 146160.Item name: cps transverse pin 6pk 28mm, catalog number: 178526, lot number: 092990.Item name: oss poly tibial bushing, catalog number: 150476, lot number: 643990.Item name: oss poly lock pin, catalog number: 150478, lot number: 771690.Item name: oss reinforced yoke, catalog number: 150493, lot number: 538360.Item name: oss rs fem bushings, catalog number: 161034, lot number: 644580.Item name: oss rs axle, catalog number: 161035, lot number: 477320.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.(b)(4).

Event Description

It was reported that a patient who underwent a knee arthroplasty approximately 3 years was revised due to the implant collapsing.Attempts have been made and additional information on the reported event is unavailable 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 follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.Device history record was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required as no trends were identified.There are warnings in the package insert that this type of event can occur and risks are addressed in risk documentation.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 a patient underwent a left knee revision approximately 5 years post primary surgery, due to the implant collapsing.Attempts have been made and additional information on the reported event is unavailable at this time.

• Brand Name: COMPRESS SEGMENTAL FEMORAL REPLACEMENT SYSTEM -RED SEXP DSTL FEM 18CM LT ASSY
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6463429
• MDR Text Key: 71882958
• Report Number: 0001825034-2017-02427
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK043547
• 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,Followup,Followup
• Report Date: 11/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 09/30/2017
• Device Catalogue Number: CP111827
• Device Lot Number: 232850
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/02/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/29/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 17 YR