MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH ALLOFIT ALLOCLASSIC, SHELL WITH POLAR SCREW PLUG, UNCEMENTED, 56/KK; ALLOFIT ACETABULAR SYSTEM

Model Number N/A

Device Problems Contamination /Decontamination Problem (2895); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Date 10/08/2020

Event Type  Injury  

Manufacturer Narrative

The manufacturer received x-rays and other source documents for review 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.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.(b)(4).

Event Description

Patient was implanted on right side and underwent revision surgery due to infection.

Manufacturer Narrative

This follow-up report is being submitted to relay corrected and additional information.Event description: patient had a total hip replacement on (b)(6) 2000 and underwent revision surgery on (b)(6) 2020 due to periprosthetic joint infection.During revision surgery, a spacer was implanted.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.- x-rays: one undated x-ray has been received showing the bilateral hip implants.No anomalies relevant to the reported event were identified.- images: the received images of the explanted products were reviewed, however no conspicuous findings relevant to the reported event were identified.Product evaluation: - no product was returned.Review of product documentation: - device purpose: all involved devices are intended for treatment.- product compatibility: the product combination was approved by zimmer biomet.- dhr review: review of the device history records identified no deviations or anomalies during manufacturing.Conclusion: patient had a total hip replacement on (b)(6) 2000 and underwent revision surgery on(b)(6) 2020 due to periprosthetic joint infection.During revision surgery, a spacer was implanted.Based on the received intraoperative images, the explantation of the devices can be confirmed.However, as neither lab results nor medical records have been received, the infection cannot 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).As the infection occurred more than 20 years after implantation, the implanted products are not identified as the source or contributing to the reported infection.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.In conclusion, as the cause may be multifactorial an exact root cause could not be identified for the reported event.However, there is no indication that the implants caused or contributed to 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 Description

No change to previously reported event.

• Brand Name: ALLOFIT ALLOCLASSIC, SHELL WITH POLAR SCREW PLUG, UNCEMENTED, 56/KK
• Type of Device: ALLOFIT ACETABULAR SYSTEM
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 10780077
• MDR Text Key: 214412146
• Report Number: 0009613350-2020-00527
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• PMA/PMN Number: K003758
• 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: 04/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/15/2004
• Device Model Number: N/A
• Device Catalogue Number: 4247
• Device Lot Number: B313243
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/13/2021
• 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