MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH ALLOFIT® IT ALLOCLASSIC®, SHELL FOR ACETABULUM, UNCEMENTED, 58/LL; HIP PROSTHESIS

Model Number N/A

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Hematoma (1884); Failure of Implant (1924); Arthralgia (2355); Fibrosis (3167)

Event Date 01/18/2021

Event Type  Injury  

Manufacturer Narrative

This product is manufactured by zimmer biomet winterthur and is not cleared or distributed in the u.S.However, this report is being submitted as zimmer biomet winterthur manufactures a similar device that is cleared or distributed in the united states.Medical product: avenir®, stem, standard, cemented, 6, taper 12/14, catalog#: 01.06010.206; lot#: 2825417.The manufacturer did not receive x-rays, or other source documents for review.The manufacturer did not receive the device yet, however it is indicated by complainant that it will be returned 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).Device on transit.

Event Description

It was reported that: during the clinical study, the surgeon filled an adverse event report.He mentioned a cup - revision due to a cup-psoas conflict (avantage double mobility cup).

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: age other relevant history (b7) corrected and additional information is filled in the follwing fields: additional: a2, b7, h2 correction: b4, g3, g6, h10 investigation of this incident is currently ongoing, a follow up report will be submitted when additional information becomes available.Zimmer biomet¿s reference number of this file is (b)(4).The following reports are associated with this event: 0009613350-2022-00028.

Event Description

It was reported that: during the clinical study, the surgeon filled an adverse event report.He mentionned a cup - revision due to a cup-psoas conflict (avantage double mobility cup).

Manufacturer Narrative

Investigation results were made available.Review of event description: it was reported that during the clinical study avnir_e1303h, the surgeon filled out an adverse event report, mentioning a cup revision on jan 18, 2021 due to a cup-psoas conflict.The revision was considered by the surgeon as an acetabular implant failure.There were no complications reported during and after the surgery.The patient had an exostosis removed during surgery at the expense of the posterior wall of the cup and has a history of left acetabular fracture.Prior to implantation on (b)(6) 2015, the patient consulted an orthopaedic surgeon because of increasing pain.This pain persisted after implantation and worsened over the years.In particular in (b)(6) 2020 the appearance of a sudden pain with functional impotence led to a visit to the emergency room.A ct scan performed at the time did not reveal any loosening of the prosthesis, but a liquid effusion in the left iliopsoas muscle associated with a retroperitoneal infiltration could suggest a hematoma of the psoas or a cup-psoas conflict.Harm: s3 - non-functioning joint hazardous situation: implant impinges on other devices or the surrounding patient anatomy.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.X-rays: numerous radiological images were received: - one preoperative ap image of the pelvis, one preoperative ap and two preoperative lateral image of the left hip.All dated (b)(6) 2015.- one postoperative ap image of the pelvis dated (b)(6) 2015.- one postoperative ap and one postoperative lateral image of the left hip dated (b)(6) 2015 - one ap and one lateral image of the left hip as well as one ap image of the pelvis.All dated (b)(6) 2016.- one ap and one lateral image of the left hip dated (b)(6) 2016.- one ap and one lateral image of the left hip as well as one ap image of the pelvis.All dated (b)(6) 2016.- one ap and one lateral image of the left hip as well as one ap image of the pelvis.All dated (b)(6) 2016.- one ap and one lateral image of the left hip as well as one ap image of the pelvis.All dated (b)(6) 2017.- one ap image of the pelvis and one lateral image of the left hip.Both dated (b)(6) 2020 - one ap and one lateral image of the left hip as well as one ap image of the pelvis.All dated (b)(6) 2020.- one postoperative ap image of the left hip dated (b)(6) 2021.- one postoperative ap image of the pelvis dated (b)(6) 2021.Additionally, the following x-rays were sent to and reviewed by external radiologists (hcp): - ap pelvis dated (b)(6) 2015.- ap and oblique left hip dated (b)(6) 2015.- ap pelvis with ap and oblique left hip dated (b)(6) 2020.Per the report, on all images the left hip components are anatomically aligned and without acute abnormality.Bone quality appears normal.The acetabular inclination measures approximately 42 degrees on both ap pelvis images - there has been no change.Further, surgeon's comments received per addi on feb 2, 2022 with the following remarks (extract): x-ray check-up left hip and pelvis (b)(6) 2020 and ct scan (b)(6) 2020 with no fracture and no sign of loosening.Slight anterior protrusion of the acetabular cup.- surgical report: the surgical report for the implantation surgery dated (b)(6) 2015 has been received: procedure: post-traumatic coxarthrosis left hip: total hip prosthesis zimmer laboratory, allo fit it cup diameter 58, ceramic insert, ceramic head 32, medium neck, avenir stem cemented standard size 6, palacos gentamicine cement.Findings: no complications.Testing revealed very good stability and a balanced rotational balance.The surgical report for the revision surgery dated (b)(6) 2021 has been received: procedure: unipolar revision of a left total hip prosthesis - extraction of the acetabular implant, bone reconstruction by allograft, installation of a kerboull laboratory size 56/49 metal reinforcement, cemented dual mobility acetabular cup, zimmer biomet laboratory diameter 48, head 22 chrome cobalt, long neck, palacos gentamycin cement, open arthrolysis and removal of an exostosis at the expense of the posterior wall of the cup.Findings: extraction of the head without difficulty.Good fixation of the femoral stem, which will not be revised.Extraction of the uncemented acetabular implant without difficulty.Placement of final implants with good stability.Product evaluation: - no product was returned; therefore, visual and dimensional evaluation could not be performed.Review of product documentation: - device purpose: all involved devices are intended for treatment.- product compatibility: the compatibility check could not be performed as not all complained products are known.- dhr review: the quality records show that all specified characteristics have met the specifications valid at the time of production with no ncr with a potential correlation to the reported event was found.- review of complaint history identified no additional similar complaints for the reported item and no additional complaints for the reported part and lot combination related to the event.Conclusion: it was reported that during the clinical study avnir_e1303h, the surgeon filled out an adverse event report, mentioning a cup revision on (b)(6) 2021 due to a cup-psoas conflict.The revision was considered by the surgeon as an acetabular implant failure.There were no complications reported during and after the surgery.The patient had an exostosis removed during surgery at the expense of the posterior wall of the cup and has a history of left acetabular fracture.Prior to implantation on (b)(6) 2015, the patient consulted an orthopaedic surgeon because of increasing pain.This pain persisted after implantation and worsened over the years.In particular in (b)(6) 2020 the appearance of a sudden pain with functional impotence led to a visit to the emergency room.A ct scan performed at the time did not reveal any loosening of the prosthesis, but a liquid effusion in the left iliopsoas muscle associated with a retroperitoneal infiltration could suggest a hematoma of the psoas or a cup-psoas conflict.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).No product were returned, hence visual and dimensional evaluation could not be performed; therefore, the condition of the parts are unknown.The surgical reports for both implantation and revision surgery were received.The indication for revision surgery was not given and no type of description was provided regarding potential causation or problems seen.However, based on the remarks provided by the surgeon, the reported event can be confirmed.Additionally, the revision report mentions the removal of an exostosis at the expense of the posterior wall of the cup.Furthermore, it is noted that the patient has history of left acetabular fracture.If and to what extent the patient's medical history and finding of the exostosis may have caused or contributed to the event remains unknown.Numerous radiological images were provided prior to the implantation up until post-revision surgery.These images were sent for external review to radiologists (hcp), despite the psoas muscle involvement not being seen on x-ray.As assessment of these images were provided stating that the left hip components are anatomically aligned and without acute abnormality.The bone quality appears normal.The acetabular inclination measures approximately 42 degrees on both ap pelvis images dated (b)(6) 2015 and (b)(6) 2020 - there has been no change.In contrast to the surgeon's remarks being provided, the surgeon states that during x-ray check-up of the left hip and pelvis on (b)(6) 2020 and ct scan on (b)(6) 2020 no fracture and no sign of loosening were observed.The surgeon notes that there is a slight anterior protrusion of the acetabular cup.Based on the given information and the results of the investigation, we were not able to identify a specific root cause for this issue.No corrective actions, preventive actions, or field actions resulted after investigation of this event.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

No event update.Investigation results are now available.

• Brand Name: ALLOFIT® IT ALLOCLASSIC®, SHELL FOR ACETABULUM, UNCEMENTED, 58/LL
• 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: 13257136
• MDR Text Key: 284289067
• Report Number: 0009613350-2022-00028
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 06/23/2022

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 Expiration Date: 05/31/2022
• Device Model Number: N/A
• Device Catalogue Number: 00-8755-058-00
• Device Lot Number: 2656899
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/15/2021
• Initial Date FDA Received: 01/14/2022
• Supplement Dates Manufacturer Received: 02/02/2022; 06/23/2022
• Supplement Dates FDA Received: 03/03/2022; 06/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/21/2012
• 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: 45 YR
• Patient Sex: Male