MAUDE Adverse Event Report: ZIMMER GMBH ALLOCLASSIC, SL STEM, OFFSET, UNCEMENTED, 4, TAPER 12/14; MODIFICATION TO ALLOCLASSIC ZWEYMULLER SL OFFSET FEMORAL STEM

Model Number N/A

Device Problems Material Erosion (1214); Metal Shedding Debris (1804); Insufficient Information (3190)

Patient Problems Pain (1994); Toxicity (2333); Injury (2348); Reaction (2414)

Event Date 11/20/2018

Event Type  Injury  

Manufacturer Narrative

The manufacturer did not receive devices, x-rays, or other source documents for review as the patient has not been revised.Where lot numbers were received for the devices, the device history records were reviewed and found to be conforming.Due to fact that this is a legal claim, our legal department has been provided with the available facts from the customer.Zimmer (b)(4) legal department is well trained and passes all information concerning the case to our complaint handling department.A cause for this specific event cannot be ascertained from the information provided.Should additional information become available and an investigation result be available, that changes this assessment, an amended medical device report will be submitted.Zimmer¿s reference number of this file is (b)(4).

Event Description

The patient is pursuing a product liability claim.It was reported, that the patient was implanted an alloclassic, sl stem, offset, uncemented, 4, taper 12/14 on (b)(6) 2007 on the right side.Patient alleged that a recent bone scan and blood test showed slightly elevated chromium levels.

Manufacturer Narrative

Investigation results were made available.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 was identified.Review of event description: it was reported that the patient alleges that a recent bone scan and blood test showed slightly elevated chromium levels.He was implanted on (b)(6) 2007 with a zimmer (b)(4) stem, and a head and cup from biomet.Review of received data: implantation report dated (b)(6) 2007: preoperative diagnosis: osteoarthritis right hip; operation: a biomet magnum acetabular 56-mm cup and a 50-mm head with a standard neck length were implanted together with a zimmer alloclassic femoral stem size 4 extended offset.Hip was observed to be stable and there was no impingement after the implantation.No abnormalities noticed.Devices analysis no product was returned to zimmer (b)(4) for in-depth analysis.Root cause determination using dfmea: metallosis, aseptic loosening due to excessive wear due to micromotion in taper connection: possible: zimmer stem was combined with a device which was not allowed by zimmer in terms of compatibility at the time of the implantation; failure of connection between stem and ball head, metallosis due to fretting corrosion: wear: possible: zimmer stem was combined with a device which was not allowed by zimmer in terms of compatibility at the time of the implantation; luxation and wear of components due to insufficient range of motion for components: possible: no x-ray was received for the investigation, therefore cannot be excluded; failure of connection between stem and ball head due to insufficient connection strength between femoral head and stem: possible: zimmer stem was combined with a device which was not allowed by zimmer in terms of compatibility at the time of the implantation; failure of connection between stem and ball head due to corrosion due to wrong material combination: possible: zimmer stem was combined with a device which was not allowed by zimmer in terms of compatibility at the time of the implantation; excessive wear, disassembly of femoral head from stem, implant failure due to combination with competitor products (off label use): possible: zimmer stem was combined with a device which was not allowed by zimmer in terms of compatibility at the time of the implantation.Conclusion summary: it was reported that the bone scan and blood test of the patient showed slightly elevated chromium levels.Firstly, it should be mentioned that the alloclassic sl stem utilized for this implantation is a protasul-100 material having composition of ti6al-7nb.It is very unlikely that this material composition could lead to elevated cr levels in the blood in the event of material wear.This increase might be more possibly seen in the products composed of cocr alloys.Secondly, alloclassic sl stem was used together with head and cup belonging to biomet.This combination was not allowed by zimmer (b)(4) at the time of the implantation.Therefore we consider the root cause of this complaint as off-label use.The need for corrective measures is not indicated and zimmer (b)(4) considers this case as closed.Zimmer's reference number of this file is (b)(4).

Event Description

In addition to the report, patient underwent revision surgery due to pain, fluid collection and metallosis.

Manufacturer Narrative

This follow-up report is being filled to relay additional information, which was unknown at the time of the previous medwatch.Additional and corrected information are filled in the following fields: 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).

Manufacturer Narrative

This follow-up report is being filled to relay investigation result.Dhr review: the device manufacturing quality records indicate that the released components met all requirements to perform as intended.Trend analysis: no trigger considering the following event is identified: metallosis event description: it was reported that the patient alleges that a recent bone scan and blood test showed slightly elevated chromium levels.He received zimmer stem, and head-cup from biomet on (b)(6) 2007 during the implantation.Additional information update: subsequently, patient underwent revision surgery on (b)(6) 2018 where all the components except the stem were revised.Review of received data: implantation report dated (b)(6) 2007: preoperative diagnosis: osteoarthritis right hip operation: biomet magnum acetabular 56-mm cup and 50-mm head with a standard neck length was implanted with zimmer femoral stem size 4 extended offset.Hip was observed to be stable and there was no impingement after the implantation.No abnormalities noticed.Revision report dated (b)(6) 2018.Preoperative diagnosis: failed right total hip arthroplasty with metal-on-metal hip replacement.Operation: dark fluid from the hip joint was aspirated approximately 20 ml consistent with "metallosis" in the right hip.Evidence of significant "metallosis" within the tissues of the capsule with dark staining of the synovial tissue of the right hip consistent with a failed metal-on-metal hip replacement.Evidence of significant granular debris, which was evacuated from the hip once again consistent with a failed metal-on-metal hip replacement.The trunnion of the stem was in acceptable condition.Some osteolysis found about the proximal aspect of the femur, which was debrided to stable borders.The femoral component was evaluated.Preoperatively, it was apparent based on his radiographs that the femoral component was in varus and somewhat prominent.The femoral component was found to be well fixed and in acceptable position and version and therefore it was retained.The acetabular cup was in acceptable position and was well fixed; however, once again, there was significant staining of the synovial tissues around the hip consistent with "metallosis".Therefore the cup was revised.Device analysis: no product was returned to zimmer biomet for in-depth analysis.Review of product documentation: this device is intended for treatment.The compatibility check was performed and showed that the product combination was not approved by zimmer biomet.Ifu for alloclassic stems which was packed with the product at the time is reviewed; it states that only authorized combinations must be used.To determine whether these devices have been authorized for use in a proposed combination, please contact your zimmer sales representative or visit the zimmer website: www.Productcompatibility.Zimmer.Com.Conclusion: review of the device history records for the product did not identify any deviations or anomalies related to the reported event.The investigation results did not identify a non-conformance or a complaint out of box (coob).Patient "underwent" revision surgery due to metallosis where all the products were revised except the alloclassic stem.Alloclassic sl stem utilized for this implantation is a protasul-100 material having composition of ti6al-7nb.It is very unlikely that this material composition could lead to elevated cr levels in the blood in the event of material wear.This increase might be more possibly seen in the products composed of cocr alloys.Secondly, alloclassic sl stem was used together with head and cup belonging to biomet.This combination was not allowed by zimmer gmbh at the time of the implantation.Therefore we consider the root cause of this complaint as off-label use.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

Please refer to report 0009613350-2016-00757.

• Brand Name: ALLOCLASSIC, SL STEM, OFFSET, UNCEMENTED, 4, TAPER 12/14
• Type of Device: MODIFICATION TO ALLOCLASSIC ZWEYMULLER SL OFFSET FEMORAL STEM
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 5678260
• MDR Text Key: 45866252
• Report Number: 0009613350-2016-00757
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2012
• Device Model Number: N/A
• Device Catalogue Number: 01.00121.040
• Device Lot Number: 2406809
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 57 YR