MAUDE Adverse Event Report: ZIMMER GMBH METASUL, ALPHA INSERT, II/32; N/A

Model Number N/A

Device Problem Metal Shedding Debris (1804)

Patient Problem Local Reaction (2035)

Event Date 09/30/2016

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: metasul, head, l, 32/+4, taper 12/14, ref#: 19.32.07, lot#: 2462782; avenir müller, stem, lateral, uncemented, ha, 3, taper 12/14, ref#: 01.06010.103, lot#: 4012313; allofit alloclassic shell 52/i i, ref#: 4245 , lot#: 2489811.The following reports are associated with this event: 0009613350-2018-00643 (metasul head); 0009613350-2018-00644 (metasul alpha insert).The actual device reported in section d is not marketed in usa, but devices with similar characteristics (i.E.01.00013.409, durasul alpha einsatz neutral ø ii/32, k013935) are marketed in usa, and therefore this report was filed.Device history records (dhr): the device manufacturing quality records indicate that the released components met all requirements to perform as intended.Trend analysis: no trend considering the following event is identified: metallosis.Review of event description: it was reported that the patient's left hip was revised due to pain and femoral metallosis.Review of received data: several documents were received.Surgical report of implantation dated (b)(6) 2009: the device reference and lot numbers were given.No complications mentioned.The discharge report dated (b)(6) 2009 mentions possible (b)(6) (not confirmed).Surgical report of explantation dated (b)(6) 2016: the revision surgery was performed by another surgeon.It is mentioned that all components were removed and replaced with competitor products.It is also mentioned that a 4cm diameter of metallosis was found.The surgery time was around 3 hours.No other relevant information was found.Nothing mentioned about any kind of infection (compare to surgical report of implantation dated (b)(6) 2009).There are also some documents available between legal and (b)(6) (patient's insurance).No relevant information for the investigation.Devices analysis: no product was returned to zimmer biomet for in-depth analysis.According to the available information, the products are kept by the patient.Review of product documentation: the compatibility check was performed and showed that the product combination was approved by zimmer biomet.Root cause analysis: root cause determination using rmw for ref 19.32.07 lot 2462782 : failure of connection between stem and ball head, abrasive wear due to insufficient connection strength between stem and head due to insufficient material properties and/or design: possible, as products in question were not returned for physical investigation.Failure of connection between stem and ball head, postoperative tissue reaction, metalosis, dislocation, aseptic loosening of stem due to excessive wear due to micromotion in taper connection between stem and head (e.G fretting): possible, it is possible that micromotion between stem and head occurred.Products in question were not returned for physical investigation.Postoperative tissue reaction, metalosis, dislocation, aseptic loosening of stem due to pe or metal particle release from articulation or taper connection: possible, it is possible that metal particle release from articulation or taper connection was occurred.Products in question were not returned for physical investigation.Dislocation, subluxation, abrasive wear, loosening of components due to tissue impingement prior to proper taper fit: possible, as no specific information is available (x-rays, products).Metalosis due to design specification not met: not possible, a systematic issue with material properties would have been detected as part of the issue evaluation assessment.Dislocation, subluxation, abrasive wear due to scratches on articular surface during surgery: possible - it is possible that during the surgery scratches occurred, as the handling during surgery is out of zimmer biomet control.Failure of connection between stem and ball head, implant breakage, corrosion, metalosis dislocation, subluxation, abrasive wear due to head is implanted on a damaged stem taper; usage of a wet and/or unclean stem and/or head taper (particles between stem taper and ball head taper): possible, as no specific information is available.Dislocation, subluxation, abrasive wear, leg length discrepancy due to soft tissue laxity: possible, as no specific information is available.Root cause determination using dfmea for ref 01.00010.709 lot 2484997: mal-function of articulation, leading to excessive wear, corrosion, metal ion release due to off label use, combination with competitor products eg.Different inserts, not compatible screws: not possible: the compatibility check was approved.Increased wear, loosening or fracture of components due to patient with high body weight: possible: patient has a bmi of 28.8.Mal-function of device, leading to excessive wear, corrosion, metal ion release, loss of connection, dislocation of insert due to off label use, combination with non approved zimmer biomet products (eg.Different inserts, not compatible screws, implant and instruments): not possible: the compatibility check was approved.Conclusion summary: it was reported that the patient's left hip was revised due to pain and femoral metallosis.The patient (dob aug 6, 1955, 156 cm, 70 kg, bmi 28.8) was implanted in 2009 with avenir stem, allofit shell and metasul head and revised in 2016 due to pain and metallosis.The device manufacturing quality records indicate that the released components (ref 19.32.07 lot 2462782 / ref 01.00010.709 lot 2484997 / ref 01.06010.103 lot 4012313 / ref 4245 lot 2489811) met all requirements to perform as intended.The implants were in vivo for more than 7 years.The revision surgery was performed by another surgeon than the implantation.The received documentation showed that all components were revised in the revision surgery and replaced with competitor products.Metallosis was found during the revision surgery (4cm diameter).No further relevant information available in the received documentation.Neither x-rays nor devices or photos of the explanted implants were received; therefore the condition of the components is unknown.Based on the given information and the results of the investigation, we were not able to identify a specific root cause for this issue.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 (b)(4).

Event Description

A product liability claim was raised.It was reported that the patient was implanted a metasul head and metasul insert on the left hip was revised due to pain and femoral metallosis after 7,5 years in vivo.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.X-rays were received and reviewed: x-ray report ((b)(6) 2009).X-ray report ((b)(6) 2015).Bone scan report ((b)(6) 2016).Bone scan report ((b)(6) 2016).X-ray report ((b)(6) 2016).Bone scans ((b)(6) 2017 and (b)(6) 2017).Conclusion summary it was reported that the patient's left hip was revised due to pain and metallosis of the femur.The patient ((b)(6), 156 cm, (b)(6), bmi 28.8) was implanted in 2009 with avenir stem, allofit shell and metasul head and revised in 2016 due to pain and metallosis.The device manufacturing quality records indicate that the released components (ref 19.32.07 lot 2462782 / ref 01.00010.709 lot 2484997 / ref 01.06010.103 lot 4012313 / ref 4245 lot 2489811) met all requirements to perform as intended.The implants were in vivo for more than 7 years.The 6 years post-operative x-ray report states that the thp appearing in a good position.The revision surgery was performed by another surgeon than in the implantation.The received documentation showed that all components were revised in the revision surgery and replaced with competitor products.Metallosis was found during the revision surgery (4cm diameter).No further relevant information available in the received documentation.However, neither devices nor photos of the explanted implants were received; therefore the condition of the components is unknown.Based on the given information and the results of the investigation, we were not able to identify a specific root cause for this issue.The need for corrective measures is not indicated and zimmer (b)(4) considers this case as closed again.(b)(4).

Event Description

No change to previously reported event.

• Brand Name: METASUL, ALPHA INSERT, II/32
• Type of Device: N/A
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 7633398
• MDR Text Key: 112152433
• Report Number: 0009613350-2018-00644
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Type of Report: Initial,Followup
• Report Date: 05/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/30/2013
• Device Model Number: N/A
• Device Catalogue Number: 01.00010.709
• Device Lot Number: 2484997
• Other Device ID Number: NOT AVAILABLE
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/02/2019
• 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: 61 YR
• Patient Weight: 70