MAUDE Adverse Event Report: ZIMMER GMBH UNKNOWN HEAD ADAPTOR

Model Number N/A

Device Problem Metal Shedding Debris (1804)

Patient Problems Pain (1994); Reaction (2414)

Event Date 06/30/2014

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: item: metasul durom, component for acetabulum item#: 01.00214.050 lot#: unknown, item: metasul ldh, head, 44, code j, taper 18/20 item#: 01.00181.440 lot#: unknown, item: unknown avenir muller stem item#: unknown lot#:unknown.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 (b)(4) winterthur legal department have already passed all information that was received from the lawyer, to our complaint handling department.By experience zimmer (b)(4) never gets more information except for the one that has been already covered in the final report.Patients¿ advocates only provide to zimmer (b)(4) 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.Trend analysis: trend has been identified and capa was initiated and performed.Device history records (dhr): as no lot numbers were provided for the devices, the device history records could not be reviewed.Missing device data information was requested but was not available.At zimmer (b)(4) 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 (b)(4) 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.Review of event description: it was reported that a patient had a metal-on-metal winterthur hip system implanted on (b)(6) 2009 and was revised on (b)(6) 2014 due to pain, fluid collection, alval, metallosis and elevated metal ions in blood.After revision, an mri showed a pseudotumor.Review of received data: no medical data such as x-rays, surgical notes or any other case-relevant documents received.Devices analysis: no product was returned to zimmer biomet for in-depth analysis.Review of product documentation: a tissue reaction like metallosis, pseudotumor or metal allergy can be a post-operative risk for metal on metal (mom).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.Conclusion: no further investigation required as this issue is known and addressed in (b)(4) (error pattern: potential early revision of the acetabular component due to loosening, implant migration or unresolved pain, higher ion release).At least one of these error patterns is observed in this event.The need for corrective measures is not indicated and zimmer (b)(4) considers this case as closed again.Zimmer¿s reference number of this file is (b)(4).The following reports are associated with this event: 0009613350 - 2016 - 01388 - 4, 0009613350 - 2018 - 00588, 0009613350 - 2018 - 00591.

Event Description

The patient is pursuing a product liability claim.It was reported that the patient was implanted an unknown head adaptor on the right side.Subsequently, patient was revised due to pain, elevated metal ions, fluid collection; intraoperatively, pseudotumor like alval and metallosis.

• Brand Name: UNKNOWN HEAD ADAPTOR
• Type of Device: UNKNOWN
• 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: 7576828
• MDR Text Key: 110331155
• Report Number: 0009613350-2018-00590
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: PNA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date: 06/07/2018

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 HEAD ADAPTOR
• Device Lot Number: UNKNOWN
• Other Device ID Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/09/2018
• Initial Date FDA Received: 06/07/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 72 YR