MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH METASUL HEAD 28MM "S" 12/14; HIP PROSTHESIS

Model Number N/A

Device Problems Biocompatibility (2886); Insufficient Information (3190)

Patient Problems Metal Related Pathology (4530); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/15/2021

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 products: metasul, alpha insert, gg/28; catalog#: 01.00010.407; lot#: 2220524; fitmore, shell with screw cones, uncemented, 48/gg; catalog#: 01.00024.548; lot#: 2213918; vite spon.Tit.Diam.6,5x30; catalog#: 02.06000.030; lot#: 040104d; vite spon.Tit.Diam.6,5x25, gg/28; catalog#: 02.06000.025; lot#: 040111c.Therapy date: (b)(6) 2021.The manufacturer received other source document for review.The manufacturer did not receive the device for investigation.Where lot numbers were received for the devices, 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 an unknown side and underwent a revision surgery due to metallosis.

Event Description

Investigation has been completed.

Manufacturer Narrative

Investigation results were made available.Event description: it was reported that the products were implanted on (b)(6) 2004 and revised on (b)(6) 2021 due to metallosis.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.Patient data: a.G., 73 years of age.No medical data relevant to the case has been received.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 was performed and showed that the product combination was approved by zimmer biomet.Dhr review: review of the device history records identified no deviations or anomalies during manufacturing.Conclusion: it was reported that the products were implanted on (b)(6) 2004 and revised on (b)(6) 2021 due to metallosis.The devices were not returned; therefore, a device examination could not be performed.In addition, no medical records have been received; therefore, the reported event could not be confirmed.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).Due to the significant lack of information, an investigation could not be conducted; therefore, the reported event could not be confirmed.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).The following reports are associated with this event: 0009613350-2021-00075-1.

• Brand Name: METASUL HEAD 28MM "S" 12/14
• Type of Device: HIP PROSTHESIS
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 11337386
• MDR Text Key: 232340223
• Report Number: 0009613350-2021-00072
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 08/11/2021

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: 02/15/2009
• Device Model Number: N/A
• Device Catalogue Number: 19.28.05
• Device Lot Number: 2207154
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/01/2021
• Initial Date FDA Received: 02/17/2021
• Supplement Dates Manufacturer Received: 07/14/2021
• Supplement Dates FDA Received: 08/11/2021
• 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: 73 YR