MAUDE Adverse Event Report: ZIMMER GMBH REVITAN®, DISTAL PART, STRAIGHT, UNCEMENTED, 18/200; HIP IMPLANT

Model Number N/A

Device Problem Fracture (1260)

Patient Problem Failure of Implant (1924)

Event Date 11/03/2023

Event Type  Injury  

Event Description

It was reported that the patient had a revision surgery due to broken implant approximately seven (9) years after implantation.Due diligence is in progress for this complaint; to date no additional information or product has been received.

Manufacturer Narrative

(b)(4).D10: prosthetic head biolox delta 36mm unknown lot and item #.Acetabular cup + pe unknown lot and item #.Revitanâ®, proximal part, conical, uncemented, 55, taper 12/14 item # 0100401055, lot #2756112.G2: foreign: spain.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: g3; h2; h3; h6 corrected: b5 no product was returned, or pictures provided; visual and dimensional evaluations could not be performed.A review of the device manufacturing records confirmed no abnormalities or deviations.Review of the complaint history identified additional similar complaints for the reported item and the part and lot combination.Complaints are monitored per complaint trending process in order to identify potential adverse trends.The patient was implanted with the shortest proximal component (size 55 mm), leading to a proximal location of the modular connection which was located approximately at the level of the lesser trochanter as seen on the provided radiograph.Based on the literature, this proximal position of the modular connection increases the mechanical stresses on the taper and thus increases the risk for stem fracture.As per surgical notes, the distal part was found to be perfectly integrated in the femur.Due to the lack of bone ongrowth, it can be assumed that the proximal part was not firmly fixed in the femur.All together, it is possible that loosening of the proximal component in combination with the firmly fixed distal component as well as the proximal location of the modular connection led or contributed to the pin fracture.In conclusion, based on the investigation a pin fracture of the distal revitan component can be confirmed.Nevertheless, since the cause may be multifactorial, consisting of patient- and procedure-related factors, a single definitive root cause could not be identified.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

It was reported that the patient had a revision surgery due to broken implant approximately nine (9) years after implantation.Due diligence is in progress for this complaint; to date no additional information or product has been received.

• Brand Name: REVITAN®, DISTAL PART, STRAIGHT, UNCEMENTED, 18/200
• Type of Device: HIP IMPLANT
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 18312623
• MDR Text Key: 330298404
• Report Number: 0009613350-2023-00693
• Device Sequence Number: 1
• Product Code: KWY
• UDI-Device Identifier: 00889024592902
• UDI-Public: (01)00889024592902(17)181130(10)2734336
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K192236
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/30/2018
• Device Model Number: N/A
• Device Catalogue Number: 0100405218
• Device Lot Number: 2734336
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/14/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/13/2013
• 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
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 85 YR
• Patient Sex: Male
• Patient Weight: 98 KG