MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH DURASUL INLAY

Model Number N/A

Device Problem Naturally Worn (2988)

Patient Problems Failure of Implant (1924); Osteolysis (2377); Insufficient Information (4580)

Event Date 08/25/2020

Event Type  Injury  

Manufacturer Narrative

Medical product: fitmore cup, size 48 hip impl win gen; catalog no#: unknown; lot#: unknown; cr-co head medium sized hip impl win gen; catalog no#: unknown; lot#: unknown.The manufacturer received user report for review.As no lot number was provided, the device history records could not be reviewed.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 there was a wear on polyethylene inlay without any symptoms.

Event Description

No change to previously reported event.

Manufacturer Narrative

This follow-up report is being submitted to relay corrected and additional information.Event description: it was reported that the patient underwent a revision surgery due to eccentric early wear of the polyethylene inlay without anamnestically clear onset of symptoms.Review of received data: no medical data relevant to the case has been received.Due diligence: no further due diligence required as all required information to support the conclusion was already requested.Product evaluation: no product was returned; therefore, visual and dimensional evaluation could not be performed.Review of product documentation: document review could not be performed due to unknown product identification.Device purpose: all involved devices are intended for treatment.Product compatibility: the compatibility check could not be performed due to missing product identification.Conclusion: it was reported that the patient underwent a revision surgery due to eccentric early wear of the polyethylene inlay without anamnestically clear onset of symptoms.The investigation did identify a nonconformance or a complaint out of box (coob).No exact product identification has been provided.The dimensions of the involved products are unknown; therefore, no device history records could be reviewed.Neither x-rays, operative notes, office visit notes, nor devices or photos of the devices were received; therefore, the condition of the components is unknown.Patient factors that may have affected the performance of the components such as bone quality, activity level, type of activity (low impact vs.High impact), and relevant medical history are unknown.Adherence to rehabilitation protocol is unknown.Due to no x-rays being received, the implant position and possible contribution to the reported eccentric wear of the polyethylene inlay can not be determined.Based on the severely limited availability of information, we were not able to identify a specific root cause for this issue.Based on the investigation the reported event cannot be confirmed.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

After investigation and closure of this complaint, the following additional information was received: - affected side: right hip.- year of initial implantation: 2004.Therefore the investigation has been updated and this report is being sent.

Manufacturer Narrative

After investigation and closure of this complaint, the following additional information was received: - affected side: right hip.- year of initial implantation: 2004.1.Event description: it was reported that the patient underwent a revision surgery due to eccentric early wear of the polyethylene inlay on the right hip without anamnestically clear onset of symptoms.Harm: s3 - non-functioning joint hazardous situation: implant deteriorates, breaks or loses function postoperatively.2.Review of received data: - no medical data relevant to the case has been received.- due diligence: no further due diligence required as all required information to support the conclusion was already requested.3.Product evaluation: - no product was returned; therefore, visual and dimensional evaluation could not be performed.4.Review of product documentation: document review could not be performed due to unknown product identification.- device purpose: all involved devices are intended for treatment.- product compatibility: the compatibility check could not be performed due to missing product identification.- x-rays: three intraoperative fluoroscopic images dated (b)(6), 2020 were received.One ap pelvis x-ray image dated (b)(6), 2020 (postoperative) was received, showing a bilateral hip replacement.Additionally, one right lateral hip x-ray has been received.No x-rays between the date of implantation in the year 2004 up to prior of the revision surgery on (b)(6), 2020 have been received.These images have been assessed by an external healthcare provider (radiologist) with the following review: fluoroscopic images demonstrate ongoing right hip arthroplasty.Pelvis and right hip images demonstrate anatomic alignment of the right hip arthroplasty.There is no acute osseous abnormality.- revision report, (b)(6), 2020 indication: intermittent pain in the right hip without trauma event.Significant eccentric abrasion of the inlay and small osteolysis around the acetabulum.Procedure: u-shaped capsulotomy.This is clearly thickened and shows villi, indicative of abrasion problems.Removal of the femoral head.Circumferential debridement of the cup.Due to significant abrasion and extreme scarring, respectively abrasion granulomas of the capsule, it was decided to explant the cup.This could be removed with little bone loss.Insertion of the definitive cup size 50 with autograph and two screws.Insertion of a durasul inlay.No luxation tendency, good tension.Implantation of a xl biolox option femoral head.5.Conclusion: it was reported that the patient underwent a revision surgery due to eccentric early wear of the polyethylene inlay in the right hip without anamnestically clear onset of symptoms.The quality records of the involved devices could not be reviewed due to missing product identification.The investigation did identify a nonconformance or a complaint out of box (coob).Based on the received revision report, the reported event can be confirmed.Neither any postoperative images after the implantation in 2004 up to the revision surgery on (b)(6), 2020 nor the implantation report have been received.As no x-rays being received that were taken before the revision surgery, the implant position and possible contribution to the reported eccentric wear of the polyethylene inlay cannot be determined.Additionally, the explanted products were not returned for investigation and no intraoperative pictures or pictures of the explanted products have been received.It is possible that due to the long time in vivo (around 16 years) the insert was naturally worn which accumulated over the years.If and to what extend surgical and / or patient factors may have played a role in the wear f the insert remains 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 switzerland manufacturing gmbh considers this case as closed.Zimmer biomet's reference number of this file is (b)(4).

• Brand Name: DURASUL INLAY
• Type of Device: DURASUL INLAY
• 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: 10816477
• MDR Text Key: 217112851
• Report Number: 0009613350-2020-00534
• Device Sequence Number: 1
• Product Code: KWB
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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: 11/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/20/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 48 YR
• Patient Sex: Male