MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH AVENIR MULLER, STEM, LATERAL, UNCEMENTED, HA, 3, TAPER 12/14; AVENIR MULLER STEM

Model Number	N/A
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	07/27/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: shell porous with cluster holes 54 mm; catalog no#: 00-6202-054-22; lot#: 64005417.Liner standard 3.5 mm offset 36 mm i.D.For use with 50/52/54 mm o.D.Shells; catalog no#: 00-6305-050-36; lot#: 64443428.Bone screw self-tapping 6.5 mm dia.25 mm length; catalog no#: 00-6250-065-25; lot#: 64504218.Concomitant medical products - therapy date: (b)(6) 2020.The manufacturer did receive per 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.(b)(4).
Event or Problem Description
Patient was implanted on the unknown side and underwent revision surgery due to infection.
Additional Manufacturer Narrative
Event description: it was reported that the patient underwent an initial tha surgery on (b)(6) 2019 and had revision surgery on (b)(6) 2020 due to periprosthetic infection.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.- no medical documents have been received.Product evaluation: no product was returned; therefore, product 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 from www.Productcompatibility.Zimmer.Com 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.- ncr(s): lot: 2947243: 1 part was scrapped due to internal handling error leading to surface damage.No ncr with a potential correlation to the reported event was found.- sterilization certificate: the gamma sterilization specification of the devices certifies the suitability of sterilization.The irradiation certificates of the affected lot numbers have been reviewed and was found to be according to specifications.Conclusion: it was reported that the patient underwent an initial tha surgery on sep 09, 2019 and had revision surgery on (b)(6), 2020 due to periprosthetic infection.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).As neither surgical reports nor lab results have been received, the reported event cannot be confirmed.Sterilization certifications were reviewed and found to be conforming with no applicable deviations.Devices were verified to have gone through acceptable sterilization process following iso/aami/astm & eu published guidelines.There are multiple factors that may contribute to an infection that are outside the control of zimmer biomet, such as external factors, i.E.Hospital/surgical environment, provider related risk factors,  and/or patient comorbidities/risk factors.As there are no indications of a product or process issues identified affecting implant safety or effectiveness, therefore implanted products are not identified as the source or contributing to the reported infection.Based on the given information and the results of the investigation, we were not able to identify a specific root cause for the infection.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 or Problem Description
No change to previously reported event.

• Brand Name: AVENIR MULLER, STEM, LATERAL, UNCEMENTED, HA, 3, TAPER 12/14
• Common Device Name: AVENIR MULLER STEM
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 10441412
• Report Number: 0009613350-2020-00387
• Device Sequence Number: 2676403
• Product Code: LZO
• UDI-Device Identifier: 00889024590960
• UDI-Public: 00889024590960
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K123392
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/04/2020

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 05/31/2023
• Device Model Number: N/A
• Device Catalogue Number: 01.06010.103
• Device Lot Number: 2947243
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/27/2020
• Supplement Date Received by Manufacturer: 11/04/2020
• Initial Report FDA Received Date: 08/24/2020
• Supplement Report FDA Received Date: 11/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Weight: 50