MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH METASUL DUROM, COMPONENT FOR FEMUR, CEMENTED, 50/P; DUROM HIP RESURFACING SYSTEM, FEMORAL COMPONENTS

Model Number N/A

Device Problems Fracture (1260); Material Integrity Problem (2978); Naturally Worn (2988); Osseointegration Problem (3003); Patient Device Interaction Problem (4001)

Patient Problems Failure of Implant (1924); Pain (1994); Depression (2361)

Event Date 06/19/2012

Event Type  Injury  

Manufacturer Narrative

Medical product: palacos lvg 1x40 single; item# : 00111914001; lot# : 71794257.Zimmer mmc, cup, uncemented, 56 mm/48 mm, code n; item# : 0100634056; lot# : 2564524.Therapy date: (b)(6) 2012.The manufacturer did not receive x-rays for review.Other source documents were received and will be reviewed as part of ongoing investigation.The manufacturer did not receive the device for investigation.The device history records were reviewed and found to be conforming.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

Patient was implanted on right side.About 5 weeks post the hip resurfacing the patient experienced acute onset of pain and the surgeon reported femoral neck fracture.Patient underwent revision surgery.During the surgery sclerosis on higher area of the bone due to rubbing and wearing down was reported.

Event Description

No change to previously reported event.

Manufacturer Narrative

This follow-up report is being submitted to relay corrected and additional information.Additional: h2, h6.Correction: b4, g3, g6, h10.Event description: it was reported that the patient underwent an initial hip resurfacing procedure on (b)(6) 2012.About 5 weeks post the hip resurfacing the patient experienced acute onset of pain and the surgeon reported femoral neck fracture.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.Surgical report: surgical report, dated (b)(6) 2012: review of the available records by a health care professional found that the patient experienced acute onset of pain, with x-rays showing a femoral neck fracture.After removed of the fractured femoral neck, there was some scleroris of the bone, due to rubbing and wear down.Product evaluation: no product was returned; therefore, visual and dimensional evaluation could not be performed.Review of product documentation: device purpose: this device is intended for treatment.Product compatibility: the product combination was not approved by zimmer biomet.Dhr review: review of the device history records identified no deviations or anomalies during manufacturing.Ncr's: no ncr with a potential correlation to the reported event was found.Conclusion: it was reported that the patient underwent an initial hip resurfacing procedure on (b)(6)2012.About 5 weeks post the hip resurfacing the patient experienced acute onset of pain and the surgeon reported femoral neck fracture.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 given information and the results of the investigation, we were not able to identify a specific root cause for this issue.It was noted that a 50mm femoral component (code p) was used in conjunction with a 56/48 mm mmc cup (code n) which is not a zimmer biomet approved combination.However, it cannot be determined if this contributed to the reported event.The reported product has been obsoleted or is no longer being manufactured 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 additional information on the reported event.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated: h6, h10.Device is used for treatment.Medical records and radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: it was reported by patient's legal counsel that the patient underwent a right hip revision procedure approximately eight years and four months post implantation.The patient was converted to a total hip arthroplasty with the initial cup retained due to femoral neck fracture.The patient did well until he presented with pain, swelling, and elevated metal ions.During the revision, significant osteolysis, trunnionosis, metallosis, and pseudotumor were confirmed.The zb stem was left in place; all other components were revised with competitor product.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

No further event information available at the time of this report.

• Brand Name: METASUL DUROM, COMPONENT FOR FEMUR, CEMENTED, 50/P
• Type of Device: DUROM HIP RESURFACING SYSTEM, FEMORAL COMPONENTS
• 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: 11957664
• MDR Text Key: 254845550
• Report Number: 0009613350-2021-00271
• Device Sequence Number: 1
• Product Code: KXA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K070292
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/31/2016
• Device Model Number: N/A
• Device Catalogue Number: 01.00211.150
• Device Lot Number: 2610545
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/07/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/09/2011
• 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 Sex: Male
• Patient Weight: 73 KG