MAUDE Adverse Event Report: ZIMMER GMBH METASUL LDH, HEAD, 44, CODE J, TAPER 18/20; N/A

Model Number N/A

Device Problem Metal Shedding Debris (1804)

Patient Problem Reaction (2414)

Event Date 02/19/2018

Event Type  Injury  

Manufacturer Narrative

This report is being filled to relay additional information, which was unknown at the time of the initial medwatch: (b)(6), exact implant date: (b)(6) 2010, implant and revision surgeon: dr.(b)(6), implant and revision hospital: (b)(6) medical center, reason for revision: metallosis, lot# and ref# received.Concomitant medical products according: item: zimmer mmc, cup, uncemented, 52 mm/44 mm, code j catalog #: 01.00634.052 lot #: 2522499, item: metasul ldh, head adapter, m, 0, taper 12/14-18/20 catalog #: 01.00185.146 lot #: 2532164, item: alloclassic sl stem 3 12/14 catalog #: 2843 lot #: 2526284.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.As soon as supplemental information becomes available an updated report will be submitted.This product is manufactured by zimmer biomet (b)(4) and is not cleared or distributed in the u.S.However, this report is being submitted as zimmer biomet (b)(4) manufactures a similar device that is cleared or distributed in the united states under 510(k) number k091973.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.The manufacturer did not receive x-rays, or other source documents for review.The device history records were reviewed and found to be conforming.An e-mail requesting the following additional information was sent on april 14, 2018 to the appropriate representatives.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).Note: another case for the same patient was opened: (b)(4).The following reports are associated with this event: 0009613350-2018-00418-1, 0009613350-2018-00621.

Event Description

A patient is pursuing a product liability claim.It was reported that the patient had a tha on the right side and underwent to revision surgery approximately eight years post-implantation due to metallosis.During this revision surgery, the metasul ldh, head, 44, code j, taper 18/20 was explanted.

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 trend considering the following event is identified: revision due to metallosis event description: today, march 9, 2018, legal received notification of a new claim.(b)(6) stated that she received a mmc cup by dr.(b)(6) in (b)(6) around (b)(6) 2010, into her right hip.She was revised on (b)(6) 2018, and is seeking compensation.There is a complaint file in etq, however that is for her left hip which was a durom.We have no additional information to report, but will forward any supplemental information to you upon receipt.Review of received data: - primary surgical report dated (b)(6) 2010: pre-operative diagnosis: severe osteoarhrisis, right hip operation: allcalssic stem size 3 , mmc cup uncemented size 52/44, ldh head 44 and adapter were implanted with success.No abnormalities were observed in the report.-revision surgery report dated (b)(6) 2018: -pre-operative diagnosis: failed right total hip arthroplasty metal-on-metal cup -indication: clinical evidence of metallosis -operation: when the posterior capsule was entered quite a bit of fluid was encountered.Multihole size 54mm cementless cup with screws, 36mm hooded liner and biolox option ceramic head 36mm size were implanted.No other findings were described.Device analysis: no product was returned to zimmer biomet for in-depth analysis.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 sap dfmea: - increased release of wear particles due to 3rd body wear due to particles possible: product was not received, therefore cannot be excluded.- increased release of wear particles due to clamping and impingement possible: no x-rays were returned for the investigation, therefore cannot be excluded.- increased release of wear particles due to scratches on articulated surface from surgeons possible: product was not received, therefore cannot be excluded.- increased release of wear particles due to dislocation, subluxation possible: no x-rays were returned for the investigation, therefore cannot be excluded.- : increased wear due to reduced sphericity due to reduced stiffness due to weight reduction groove and depending on head diameter and offset possible: product was not received, therefore cannot be excluded.- increased wear due to reduced sphericity due to assembling force not possible: a systematic issue with design and/or material properties would have been detected as part of the issue evaluation assessment - invivo higher wear than expected based on invitro results due to risk of difference between invivo and invitro behavior: tribology not possible: a systematic issue with design and/or material properties would have been detected as part of the issue evaluation assessment - invivo higher amount of metal ions/particles due to corrosion and wear due to risk of difference between invivo and invitro behavior: combination of 19-22 not possible: a systematic issue with design and/or material properties would have been detected as part of the issue evaluation assessment - increased wear due to insufficient articulation surface overlap (difference between sra and ldh) not possible: a systematic issue with design and/or material properties would have been detected as part of the issue evaluation assessment.- release of corrosion particles and ions due to wrong material paring not possible: - adverse body reactions (like cyst formation, pseudotumors, alval, metallosis and pain) due to ion release due to increased ion release due to increased metal surface (without wear and fretting corrosion) not possible: a systematic issue with design and/or material properties would have been detected as part of the issue evaluation assessment - adverse body reactions (like cyst formation, pseudotumors, alval, metallosis and pain) due to ion release due to increased ion/wear release due to increased articular diameter not possible: a systematic issue with design and/or material properties would have been detected as part of the issue evaluation assessment - increased wear, loss of taper connection, dislocation due to high patient activity possible: unknown, therefore cannot be excluded - increased wear, fretting corrosion (lever torque) due to patient with high body weight and bmi possible: unknown, therefore cannot be excluded - instable taper connection massive metal wear due to combination of various/competitor adapter systems (wrong material/false adapter) not possible: pairing was correct.- increased wear, loss of taper connection, dislocation due to increased ante/retro-version of the stem may increase joint loading possible: no x-rays were returned for the investigation, therefore cannot be excluded.Conclusion: patient underwent revision surgery of the mom thr due to metallosis after approximately 8 years in-vivo time.Except the stem, all the components were revised.Raw material certificates confirm that the devices were manufactured according to the material specifications.Review of the device history records for the products did not identify any deviations or anomalies related to the reported event.Possible causes of the reported event include increased wear due to too small clearance, too large clearance, component malpositioning, damaged component during operation, 3rd body wear due to particles, dislocation and patient related causes.It is not known to which extent these factors had a role.It is not possible to find a root cause in the absence of valuable medical data like x-rays for the investigation and the explants.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).

• Brand Name: METASUL LDH, HEAD, 44, CODE J, TAPER 18/20
• Type of Device: N/A
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 7600280
• MDR Text Key: 111003062
• Report Number: 0009613350-2018-00618
• Device Sequence Number: 1
• Product Code: KWA
• 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: consumer
• Type of Report: Initial,Followup
• Report Date: 09/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/31/2013
• Device Model Number: N/A
• Device Catalogue Number: 01.00181.440
• Device Lot Number: 2468047
• Other Device ID Number: 00889024422506
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/12/2018
• 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: 87 YR