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

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Anemia (1706); Low Blood Pressure/ Hypotension (1914); Blood Loss (2597)

Event Date 09/09/2020

Event Type  Injury  

Manufacturer Narrative

Medical products: g7 pps ltd acet shell 50d.Catalog#: 010000662; lot#: 6727744.Liner neutral 36 mm i.D.Size d for use with g7 acetabular system only.Catalog#: 30103604; lot#: 64797263.Therapy date: unknown.The manufacturer received other source documents for review.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 the left side.Subsequently patient experienced post-operative blood loss and hypotension requiring medical intervention and thereby prolonging hospitalization.

Manufacturer Narrative

This follow-up report is being submitted to relay corrected and additional information.Event description: the patient had an initial left tha on (b)(6) 2020.Subsequently, the patient experienced post-operative acute blood loss anemia and hypotension requiring medical intervention and prolonged hospitalization.Resolved (b)(6) 2020.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.- mymobility clinical study report: - patient data: id (b)(6) , female, born (b)(6) 1951, 162 cm, 74 kg, bmi 28.2, significant past medical history consisting of oa, dizziness and ha.- findings: pre-op health score 70, moderate pain, no intra-operative complications identified, acute blood loss anemia and hypotension requiring medical intervention (possible transfusion, fluid replacement therapy, or both) prolonging hospitalization.Product evaluation: - products remain implanted.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.Conclusion: the patient had an initial left tha on (b)(6) 2020.Subsequently, the patient experienced post-operative acute blood loss anemia and hypotension requiring medical intervention and prolonged hospitalization.Resolved (b)(6) 2020.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).Procedural related complications are influenced by the type of surgery, patients pre-existing comorbid state, and perioperative management.Anemia can be associated with different medical conditions or can be directly related to blood loss during a trauma, surgical procedure or surgical complication.Anemia depending on the cause can be monitored and treated minimally or if hemoglobin is significantly low, it could be indicated that medical intervention is necessary to treat, i.E.Administering blood or other medical interventions.As postoperative developement of anemia develops with no other identified cause, this signifies a postoperative procedure-related complication.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

No change to previously reported event.

• Brand Name: AVENIR MLLER, STEM, STANDARD, UNCEMENTED, HA, 3, TAPER 12/14
• Type of Device: AVENIR MULLER STEM
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 10780096
• MDR Text Key: 214407316
• Report Number: 0009613350-2020-00521
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 00889024590953
• UDI-Public: 00889024590953
• Combination Product (y/n): N
• PMA/PMN Number: K123392
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 02/24/2021

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?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/31/2023
• Device Model Number: N/A
• Device Catalogue Number: 01.06010.003
• Device Lot Number: 2966718
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/22/2020
• Initial Date FDA Received: 11/03/2020
• Supplement Dates Manufacturer Received: 02/18/2021
• Supplement Dates FDA Received: 02/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Weight: 75