MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH SULOX, HEAD, L, 32/+3.5, TAPER 12/14; HIP PROSTHESIS

Model Number N/A

Device Problems Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Joint Laxity (4526)

Event Date 08/17/2009

Event Type  Injury  

Manufacturer Narrative

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.Medical product: alloclassic, sl stem, uncemented, 4, taper 12/14; catalog#: 2844; lot#: 2467943.Therapy date: (b)(6) 2009.The manufacturer received x-rays were received and will be reviewed as part of ongoing investigation.The manufacturer did not receive the device for investigation.The lot number of the device was received.The device history records will be reviewed during investigation.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.Zimmer biomet¿s reference number of this file is (b)(4).

Event Description

It was reported that the patient underwent a revision surgery due to aseptic loosening.

Manufacturer Narrative

This follow-up report is being filled to relay additional information, which was unknown at the time of initial medwatch.New information received: patient weight.Patient identifier.Corrected and additional information is filled in the follwing fields: investigation of this incident is currently ongoing, a follow up report will be submitted when additional information becomes available.The following reports are associated with this event: 0009613350-2021-00536.Zimmer biomet¿s reference number of this file is (b)(4).

Event Description

No change of the event description.

Manufacturer Narrative

Investigation results were made available.Investigation and conclusion.1.Event description: according to the documentation received, the patient underwent a right total hip arthroplasty on (b)(6), 2009 at (b)(6).Subsequently, the patient underwent revision surgery on (b)(6), 2009 due to pain and loosening of the acetabular shell.During revision surgery the acetabular shell, the liner and the femoral head were replaced.Harm: s3 - pain or ache, moderate.Hazardous situation: loss of fixation or non-integration of an implant.2.Review of received data: - due diligence: no further due diligence required as all required information to support the conclusion is available or was already requested.Please note that the provided documents have been translated from german into english and the content relevant to this complaint has been summarized.- letter from (b)(6) to zimmer biomet (b)(6) gmbh ((b)(6), 2021): submission of the following attachments: -.1 implant pass.-.2 photographic documentation.-.3 radiograph of current condition.-.4 confirmation of stay from (b)(6), dated (b)(6), 2021 including medical discharge letter.-.5 memo with factual assessment.- attachment.5 memo (b)(6), 2021): factual assessment: the patient underwent right hip surgery on (b)(6), 2009.Subsequently, acetabular loosening occurred.A second surgery was necessary.This surgery was performed on (b)(6), 2009 at the hospital in (b)(6) (doctor's letter of dr.(b)(6) dated (b)(6), 2009, confirmation of stay dated (b)(6), 2009; stay from (b)(6), 2009 to (b)(6), 2009; doctor's letter of the regional hospital in (b)(6) dated (b)(6), 2009 and (b)(6), 2009, preliminary discharge report).- attachment.1 implant pass zimmer: right hip, date of implantation: (b)(6), 2009 product stickers of zimmer biomet devices: - ref# (b)(4), lot# 2508116, allofit alloclassic shell uncemented 48gg.- ref# (b)(4), lot# 2500390, durasul alpha insert gg28.Product stickers of non-zimmer biomet devices: - ref# (b)(4), lot# 7010568908, konus for bioball adapter 28, merete medical gmbh.- ref# (b)(4), lot# k012844, bioball konus 4x-lang (+17.5), merete medical gmbh.- attachment.1 implant pass depuy a johnson-johnson company (undated): product stickers of zimmer biomet devices: - ref# (b)(4), lot# 2467943, alloclassic sl stem uncemented 4 - ref# (b)(4), lot# 2498129, sulox head 32+3.5, l product stickers of non-zimmer biomet devices: - ref# (b)(4), lot# 0730b429, (b)(6), falcon medical - ref# (b)(4), lot# 0627b026, siocon tps 48b, falcon medical - unmarked attachment of attachment.5 physician's letter from (b)(6) ((b)(6), 2009): patient was stationary from (b)(6), 2009 to (b)(6), 2009 diagnosis: coxarthrosis right, arterial hypertension treatment: implantation of a right total hip arthroplasty ((b)(6) medical, siocon cup 48, ceramic insert 32, alloclassic sl zemfr.4, sulox head dm 32) on (b)(6), 2009.- unmarked attachment of attachment.5 confirmation of stay from (b)(6) ((b)(6), 2009): the patient was an inpatient from (b)(6), 2009 to (b)(6), 2009.Diagnosis: aseptic acetabular loosening condition after right hip tep in (b)(6) 2009.Treatment: on (b)(6), 2009, cup replacement of right hip joint (allofit 48, ceramic inlay dm 28).Indication: patient reports a new pain symptom postop.During physiotherapy.The patient has had pain at rest with a reduction in walking distance to about 100 meters.Procedure: surgery without complications and postoperative course.3.Product evaluation: - no product was returned; therefore, no product evaluation could be performed.4.Review of product documentation: - device purpose: this device is intended for treatment.- product compatibility: the used product combination was not approved by zimmer, since zimmer has not tested the safety or effectiveness of zimmer devices in combination with non-zimmer products or components [1].- dhr review: review of the device history records identified no deviations or anomalies during manufacturing.- instruction leaflet for endoprostheses [1]: 1.Instructions for use: zimmer has not tested the safety or effectiveness of these devices for use in combination with non-zimmer products or components.If surgeons elect to assemble and implant a construct that includes components not manufactured or distributed by zimmer, they do so in reliance on their own clinical judgment and should so inform their patients.[.] only authorized combinations should 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.5.Conclusion: according to the documentation received, the patient underwent a right total hip arthroplasty on (b)(6) 2009 at (b)(6).Subsequently, the patient underwent revision surgery on (b)(6), 2009 due to pain and loosening of the acetabular shell.During revision surgery the acetabular shell, the liner and the femoral head were replaced.The quality records show that all specified characteristics have met the specifications valid at the time of production.Therefore, the investigation did not identify a nonconformance or a complaint out of box (coob).Based on the medical records received, the reported loosening of the acetabular shell leading to revision can be confirmed.Since the surgical reports and the sulox head are not available, a more detailed analysis cannot be performed; therefore, the exact reasons for the removal of the sulox head during revision surgery on (b)(6), 2009 remain unknown.The sulox head was combined with a ceramic insert from falcon medical.This combination has not been approved or tested for use and is therefore not a legally marketed product combination.Therefore, it remains unknown if and to what extent this product combination contributed to the reported event.[1] zimmer gmbh.Instruction leaflet for endoprostheses.Art.No.D 011 500 200 - edfispsw - ed.0408.The need for corrective measures is not indicated and zimmer switzerland.Manufacturing gmbh considers this case as closed.Zimmer biomet's reference number of this file is (b)(4).

Event Description

Investigation results are now available.

• Brand Name: SULOX, HEAD, L, 32/+3.5, TAPER 12/14
• Type of Device: HIP PROSTHESIS
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER SWITZERLAND MANUFACTURING 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: 12674334
• MDR Text Key: 277841111
• Report Number: 0009613350-2021-00536
• Device Sequence Number: 1
• Product Code: KWB
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2013
• Device Model Number: N/A
• Device Catalogue Number: 17.32.07
• Device Lot Number: 2498129
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/28/2009
• 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
• Treatment: SEE H10 NARRATIVE.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Weight: 76 KG