MAUDE Adverse Event Report: ZIMMER GMBH AVENIR MULLER STEM, STANDARD, UNCEMENTED, HA, 4, TAPER 12/14

Model Number	N/A
Medical Device Problem Code	Material Erosion (1214)
Health Effect - Clinical Codes	Reaction (2414); Fluid Discharge (2686)
Date of Event	11/12/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products and therapy dates: details of products: item number unknown, item name 54mm trilogy shell, lot # unknown.Item number unknown, item name unknown liner, lot # unknown.Item number 00801803202, item name femoral head sterile product do not resterilize 12/14 taper, lot # 62937377.The manufacturer received x-rays and 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.As no lot number was provided, the device history records could not be reviewed.Additional information has been requested and is currently not available.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 or Problem Description
It was reported that patient underwent revision surgery due to fluid near the greater trochanter and elevated metal ions.The femoral head was removed and a minimal amount of discoloration was noted.
Event or Problem Description
Please refer to report 0009613350-2019-00185.
Additional Manufacturer Narrative
This follow-up report is being filled to relay investigation result.Dhr review: the dhr check could not be performed as the lot number was not available.Trend analysis: no trend considering the following event is identified: elevated metal ions.Event description: it was reported that the product was implanted on (b)(6) 2015 and underwent revision on (b)(6) 2018 due to elevated metal ions.Review of received data: the provided x-ray was reviewed by dr.(b)(6), md (radiologist) see maven md reviewer case report from warsaw.Single ap view of the lower pelvis: bilateral hip arthroplasties are present and the side of concern was not specified in the case information.Notations at the right hip suggest that this is the side of concern.The components are anatomically aligned bilaterally.Heterotopic ossification is present laterally on the left.There is no evidence of osteolysis or component loosening.According to the investigation letter (b)(4) (warsaw complaint) a picture of the implanted stem was provided and black debris along with scratches could be confirmed on the stem taper surface.No further evaluation was possible using the picture provided.Device analysis: no product was returned to zimmer biomet for in-depth analysis.Review of product documentation: this device is intended for treatment.The compatibility check was performed and showed that the product combination was approved by zimmer biomet.Conclusion: it was reported that the product was implanted on (b)(6) 2015 and underwent revision on (b)(6) 2018 due to elevated metal ions.The revised avenir stem has not been received for material analysis.Therefore, the condition of the component is unknown.As the lot number of the stem is unknown, a review of the manufacturing records could not be performed.Compatibility was verified and it was found that the combination of the products reported in the complaint has been confirmed to be approved/cleared for use and is a legally marketed combination.The provided x-ray shows that the components are anatomically aligned bilaterally.There is no evidence of osteolysis or component loosening.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).

• Brand Name: AVENIR MULLER STEM, STANDARD, UNCEMENTED, HA, 4, TAPER 12/14
• Common Device Name: AVENIR MULLER STEM
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 8498428
• Report Number: 0009613350-2019-00185
• Device Sequence Number: 2675520
• Product Code: LZO
• UDI-Device Identifier: 00889024479517
• UDI-Public: 00889024479517
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K123392
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2019

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
• Operator of Device: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 01.06010.004
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/12/2018
• Supplement Date Received by Manufacturer: 06/20/2019
• Initial Report FDA Received Date: 04/10/2019
• Supplement Report FDA Received Date: 06/24/2019
• 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: 68