MAUDE Adverse Event Report: ZIMMER GMBH MOM WINTERTHUR GENERIC HIP

Model Number N/A

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Code Available (3191)

Event Date 04/10/2014

Event Type  Injury  

Manufacturer Narrative

The manufacturer did not receive x-rays, or other source documents for review.The manufacturer did not receive the device for investigation.The device history records were reviewed and found to be conforming.Additional information has been requested and is currently not available.A cause for this specific event cannot be ascertained from the information provided.As soon as supplemental information becomes available an updated report will be submitted.(b)(4).

Event Description

A patient is pursuing a product liability claim.It was reported that the patient was implanted a mom winterthur generic hip (catalogue number unknown) on the right side on (b)(6) 2006 and the patient underwent revision surgery on (b)(6) 2014 due to metallosis.

Manufacturer Narrative

Investigation results were made available.As the case at hand is a legal claim it is not suspected that the devices or additional information are being submitted for review.Zimmer gmbh winterthur legal department have already passed all information that was received from the lawyer, to our complaint handling department.By experience zimmer gmbh never gets more information except for the one that has been already covered in the final report.Patients¿ advocates only provide to zimmer gmbh as much information as they are willing to share to protect the rights of their clients.All information which has been provided for this particular case is already covered in the final report.Nevertheless, should additional information become available to us, a follow up report will be submitted.A technical investigation was not possible to be performed, as the device(s) were not at hand for investigation.However, based on the available information the investigation is conducted with outcome as follows.Device history records (dhr): as no lot numbers were provided for the devices, the device history records could not be reviewed.The missing device information has been requested but was not available at zimmer gmbh all medical devices prior release to market undergo several quality inspections as defined in our quality procedures.Our quality inspection- and deviation procedures ensure that only products fulfilling the specification are sold.These procedures are part of the overall quality management system at zimmer gmbh and get regularly audited by our notified body, competent authorities and internal and external auditors.Thus, for all products sold to the market can be assumed having a complete and correct dhr.Trend analysis: no trend analysis could be performed as no lot number was available.Review of event description: it is only known that the patient underwent tha with zimmer mom hip prosthesis on (b)(6), 2006 and was revised on (b)(6), 2014 due to metallosis and pseudo-tumor.Review of received data legal documents have been received in italian.It was reported that in november 2013 the patient noticed a persistent edema in the right inferior limb.The patient went to the hospital; a thrombophlebitis was suspected.Subsequently, the patient was diagnosed with a lymphatic insufficiency related to an inguinal lymphadenopathy.The patient had been advised by the hospital that this could have been caused by the prosthesis, which has been removed from the market due to this disadvantage.Further it is stated, that the patient has been reassessed and has been diagnosed with a "probable metallosis and therefore resulting lymphangitis of the right lower extremity".Therefore revision surgery was planned for april 10, 2014.Additionally it is mentioned, that on december 19th, 2013 the patient had an abdominal tomography (tac) which showed an hepatic anomaly.It also highlighted the presence of a coarse serous collection in the right prosthetic gluteus region.The revision in april 2014 showed abundant metallosis.A pseudo-tumor around the joint tissue was found.Devices analysis: no product was returned to zimmer biomet for in-depth analysis.According to the available information, the product location is unknown.Conclusion summary: as neither x-rays, surgical reports, nor devices or photos of the explanted implant(s) were received; therefore the condition of the component(s) is unknown.Patient factors that may affect the performance of the components such as bone quality, activity level, type of activity (low impact vs.High impact), and relevant medical history are unknown.Adherence to rehabilitation protocol is unknown.A tissue reaction like metallosis, pseudotumor or metal allergy can be a post-operative risk for metal on metal (mom).In example, metallosis of hip is well known issue in the literature dedicated to mom joint replacements, and is defined as aseptic necrosis, local necrosis or loosening of the prosthesis secondary to metallic corrosion and release of wear debris.More generally, mom hypersensitivity reactions are increasingly being recognized as a cause of osteolysis, loosening, and subsequent failure in the short- to intermediate-term follow-up of mom-thas.Moreover, complex physiological reactions like pseudotumor or metal allergy are known risks for this kind of metal-on-metal implants as stated in zimmer¿s ifus.In conclusion, due to significant lack of information, it is impossible to perform a meaningful analysis of the reported event.The need for corrective measures is not indicated and zimmer gmbh considers this case as closed.Zimmer biomet's reference number of this file is cmp-0347596.

• Brand Name: MOM WINTERTHUR GENERIC HIP
• Type of Device: MOM WINTERTHUR GENERIC HIP
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 7128788
• MDR Text Key: 95230300
• Report Number: 0009613350-2017-01763
• Device Sequence Number: 1
• Product Code: JDL
• Combination Product (y/n): N
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Type of Report: Initial,Followup
• Report Date: 08/08/2018

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: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/21/2017
• Initial Date FDA Received: 12/19/2017
• Supplement Dates Manufacturer Received: 06/29/2018
• Supplement Dates FDA Received: 08/08/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 66 YR